Surgeon'S Gloves
FDA product code KGO · Class I (low risk) · 21 CFR 878.4460 · General, Plastic Surgery
A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
560510(k) clearances
0PMA approvals
42recalls
Manufacturers
- Wrp Asia Pacific Sdn. Bhd. 20
- Molnlycke Health Care Us, LLC 16
- Ansell Healthcare Products LLC 16
- Ansell Perry 15
- Wembley Rubber Products (M) Sdn Bhd 15
- Terang Nusa Sdn Bhd 15
- Cardinal Health 13
- Medline Industries, LP 12
- Johnson & Johnson Medical, Inc. 10
- Maxxim Medical 10
- Bd Becton Dickinson Vacutainer Systems Preanalytic 9
- Lucenxia Prescience AG 9
- Allegiance Healthcare Corp. 9
- Hartalega Sdn Bhd 8
- Pt. Medisafe Technologies 8
- Safeskin Corp. 7
- Regent Medical Americas, LLC 7
- Eci Medical Technologies, Inc. 6
- Smith & Nephew Perry 6
- Baxter Healthcare Corp 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | Hartalega NGC Sdn. Bhd. | 07/28/2026SE |
| K253060 | Sterile Latex Powder Free Surgical GlovesKGO · Traditional | Protect Gloves Company Limited | 05/22/2026SE |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With…KGO · Abbreviated | Harps Europe Manufacturing GmbH | 08/19/2025SE |
| K240790 | Polyisoprene Surgical glovesKGO · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 08/23/2024SE |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 03/28/2024SE |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsKGO · Traditional | Grand Work Plastic Products Co., Ltd. | 12/20/2023SE |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…KGO · Traditional | Ansell Healthcare | 10/20/2023SE |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical GloveKGO · Traditional | Ineo Tech Sdn Bhd | 09/29/2023SE |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional | Fitone Latex Products Co., Ltd. Guangdong | 09/22/2023SE |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 08/31/2023SE |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional | Ansell Healthcare Products, LLC | 08/23/2023SE |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested…KGO · Traditional | Sentienx Sdn Bhd | 08/18/2023SE |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical GlovesKGO · Traditional | The Egyptian Company For Medical & Electronic… | 08/16/2023SE |
| K230304 | Polyisoprene Surgical GlovesKGO · Traditional | Puyang Linshi Medical Supplies Co., Ltd. | 08/09/2023SE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy DrugsKGO · Traditional | Ansell Healthcare Products, LLC | 05/26/2023SE |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsKGO · Traditional | Grand Work Plastic Products Co., Ltd. | 05/13/2023SE |
| K222350 | Sterile Nitrile Surgical Gloves Powder FreeKGO · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 04/13/2023SE |
| K222620 | Sterilized Latex Surgical GlovesKGO · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 03/23/2023SE |
| K221424 | Sterile Surgical Powder Free Latex GloveKGO · Traditional | New Era Medicare Sdn. Bhd. | 01/26/2023SE |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 10/22/2022SE |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)KGO · Traditional | Hartalega NGC Sdn. Bhd. | 09/24/2022SE |
| K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesKGO · Traditional | Guilin Hbm Health Protections, Inc. | 09/13/2022SE |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per…KGO · Traditional | Hartalega NGC Sdn. Bhd. | 05/26/2022SE |
| K211953 | Disposable Sterilized Latex Surgical GlovesKGO · Traditional | Jiangxi Kemei Medical Apparatus & Instruments… | 05/25/2022SE |
| K212596 | Sterile Latex Surgical Gloves Powder FreeKGO · Abbreviated | Amazing Rubber Products Pvt, Ltd. | 03/01/2022SE |
| K212848 | Sterile Latex Surgical Gloves Powder FreeKGO · Abbreviated | Pentavest Holdings Sdn Bhd | 12/27/2021SE |
| K210969 | NulifeKGO · Abbreviated | Mrk Healthcare Pvt, Ltd. | 11/03/2021SE |
| K211621 | Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO · Traditional | Careplus (M) Sdn Bhd | 10/06/2021SE |
| K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloveKGO · Traditional | Cardinal Health200, LLC | 09/26/2021SE |
| K211478 | Sterile Latex Surgical Gloves Powder FreeKGO · Abbreviated | Aspen Glove Sdn. Bhd. | 09/16/2021SE |
| K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional | Careplus (M) Sdn Bhd | 08/03/2021SE |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO · Traditional | Medline Industries, Inc. | 08/02/2021SE |
| K200915 | Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The…KGO · Traditional | Gx Corporation Sdn Bhd | 07/09/2021SE |
| K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional | Careplus (M) Sdn Bhd | 06/24/2021SE |
| K203030 | Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy DrugsKGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 06/11/2021SE |
| K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…KGO · Traditional | Careplus (M) Sdn Bhd | 05/27/2021SE |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims…KGO · Traditional | Eco Medi Glove Sdn. Bhd. | 02/17/2021SE |
| K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesKGO · Traditional | Guilin Hbm Health Protections, Inc. | 02/01/2021SE |
| K192933 | Polyisoprene Powder Free, Black Colour Surgical GlovesKGO · Special | Emerson & Co. Srl | 01/13/2021SE |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use…KGO · Traditional | Medline Industries, Inc. | 12/19/2020SE |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator…KGO · Traditional | Molnlycke Health Care Us, LLC | 11/22/2020SE |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs…KGO · Traditional | Medline Industries, Inc. | 11/18/2020SE |
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less…KGO · Traditional | Hartalega Sdn Bhd | 10/02/2020SE |
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested…KGO · Traditional | Pt. Medisafe Technologies | 09/16/2020SE |
| K201829 | SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)KGO · Traditional | Medline Industries, Inc. | 09/09/2020SE |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue)…KGO · Traditional | Hartalega Sdn Bhd | 06/01/2020SE |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…KGO · Traditional | Molnlycke Health Care Us, LLC | 04/10/2020SE |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical GlovesKGO · Traditional | Medline Industries, Inc. | 04/06/2020SE |
| K192988 | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGO · Traditional | Medline Industries, Inc. | 04/01/2020SE |
| K191860 | Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis PotentialKGO · Abbreviated | Semperit Technische Produkte Gesellchaft M.B.H. | 03/31/2020SE |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim…KGO · Traditional | Molnlycke Health Care Us, LLC | 03/13/2020SE |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder FreeKGO · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 03/10/2020SE |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGO · Traditional | Medline Industries, Inc. | 03/06/2020SE |
| K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with…KGO · Traditional | Medline Industries, Inc. | 02/28/2020SE |
| K190241 | Sterile Latex Surgical Glove, Powder FreeKGO · Traditional | Careglove Global Sdn. Bhd. | 12/30/2019SE |
| K191898 | Sterile Latex Powder-Free Surgical GlovesKGO · Traditional | Modern Healthcare Corp. | 12/18/2019SE |
| K190632 | Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or…KGO · Abbreviated | Lenora Glove Pvt , Ltd. | 10/24/2019SE |
| K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per…KGO · Traditional | Hartalega NGC Sdn. Bhd. | 08/16/2019SE |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical UndergloveKGO · Traditional | Hartalega NGC Sdn. Bhd. | 06/28/2019SE |
| K190782 | FlexGard Cut-Resistant Glove LinersKGO · Abbreviated | Ldi Corporation | 06/27/2019SE |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO · Traditional | Molnlycke Health Care Us, LLC | 05/24/2019SE |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…KGO · Traditional | Ansell Healthcare Products, LLC | 05/23/2019SE |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with…KGO · Traditional | Pt. Medisafe Technologies | 03/28/2019SE |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO · Traditional | Ansell Healthcare Products, LLC | 03/22/2019SE |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with…KGO · Traditional | Smart Glove Corporation Sdn. Bhd. | 01/09/2019SE |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested…KGO · Traditional | Smart Glove Corporation Sdn. Bhd. | 08/08/2018SE |
| K171550 | Sterile Latex Surgical Gloves, Powder FreeKGO · Traditional | Sanrea Healthcare Products Pvt, Ltd. | 07/13/2018SE |
| K173304 | Finessis Intense Polyisoprene Surgical GloveKGO · Special | Lucenxia Prescience AG | 04/30/2018SE |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with…KGO · Traditional | Pt. Medisafe Technologies | 04/20/2018SE |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with…KGO · Traditional | Lucenxia Prescience AG | 04/09/2018SE |
| K171375 | Gammex PI Breach Detect Powder Free Surgical GloveKGO · Traditional | Ansell Healthcare Products, LLC | 02/06/2018SE |
| K172942 | Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content…KGO · Abbreviated | Beta Healthcare Products Pvt., Ltd. | 01/08/2018SE |
| K171987 | Finessis Zero Flexylon Powder Free Sterile White Surgical GloveKGO · Special | Lucenxia Prescience AG | 10/20/2017SE |
| K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and…KGO · Traditional | Top Glove Sdn. Bhd. | 10/12/2017SE |
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with…KGO · Traditional | Wear Safe (Malaysia) Sdn. Bhd. | 09/29/2017SE |
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy DrugsKGO · Traditional | Tg Medical Sdn. Bhd. | 08/21/2017SE |
| K171898 | Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsKGO · Traditional | Better Care Plastic Technology Co., Ltd. | 08/18/2017SE |
| K171047 | Sterile Polyisoprene Powder Free Surgical GlovesKGO · Traditional | Better Care Plastic Technology Co., Ltd. | 06/22/2017SE |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use…KGO · Traditional | Cardinal Health, Inc. | 06/15/2017SE |
| K170515 | Sterile Nitrile Surgical Gloves, Powder-freeKGO · Traditional | Primus Gloves Pvt Limited | 06/09/2017SE |
| K170152 | Polychloroprene Powder Free Surgical Glove (Green)KGO · Traditional | Hartalega Sdn Bhd | 05/05/2017SE |
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesKGO · Abbreviated | Semperit Investments Asia Pte , Ltd. | 05/02/2017SE |
| K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical GloveKGO · Traditional | Lucenxia Prescience AG | 02/08/2017SE |
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsKGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 01/23/2017SE |
| K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50…KGO · Traditional | Hartalega Sdb. Bhd. | 12/20/2016SE |
| K160974 | Gammex Cut-Resistant Glove LinerKGO · Traditional | Ansell Healthcare Products, LLC | 10/28/2016SE |
| K161008 | Polyisoprene Powder Free Surgical Underglove, Polyisoprene Powder Free Surgical GloveKGO · Traditional | Hartalega Sdn Bhd | 07/28/2016SE |
| K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…KGO · Traditional | Cardinal Health, Inc. | 07/11/2016SE |
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…KGO · Traditional | Cardinal Health, Inc. | 05/12/2016SE |
| K152428 | SensiCare PI Surgical GlovesKGO · Traditional | Medline Industries, Inc. | 03/31/2016SE |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…KGO · Traditional | Cardinal Health 200, Inc. | 03/24/2016SE |
| K151694 | Gammex PI Hybrid Surgical GlovesKGO · Traditional | Ansell Healthcare Products, LLC | 03/09/2016SE |
| K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2:…KGO · Traditional | Emerson & Co. Srl | 01/15/2016SE |
| K151114 | Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves…KGO · Abbreviated | St. Marys Rubbers Pvt, Ltd. | 12/11/2015SE |
| K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera…KGO · Traditional | Medline Industries, Inc. | 11/27/2015SE |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical GloveKGO · Traditional | Lucenxia Prescience AG | 11/16/2015SE |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical GlovesKGO · Traditional | Lucenxia Prescience AG | 11/16/2015SE |
| K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free)KGO · Traditional | Anhui Anyu Latex Products Co., Ltd. | 11/16/2015SE |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with…KGO · Traditional | Pt. Medisafe Technologies | 11/02/2015SE |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content…KGO · Traditional | Terang Nusa Sdn Bhd | 09/18/2015SE |
| K150146 | Biogel PI Micro Indicator UndergloveKGO · Traditional | Molnlycke Health Care Us, LLC | 08/31/2015SE |
| K150973 | NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use…KGO · Traditional | Terang Nusa Snd Bhd | 08/04/2015SE |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy…KGO · Traditional | Pt. Medisafe Technologies | 07/14/2015SE |
| K140477 | Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesKGO · Traditional | Molnlycke Health Care Us, LLC | 03/23/2015SE |
| K142992 | TULIP Natural Rubber Latex Surgeon's Glove (Powdered)KGO · Traditional | Shanghai Jinxiang Latex Products Co., Ltd. | 03/18/2015SE |
| K140989 | Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)KGO · Traditional | Hebei Hongsen Plastics Technology Co, Ltd. | 12/22/2014SE |
| K140355 | Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling ClaimKGO · Traditional | Terang Nusa Sdn Bhd | 11/06/2014SE |
| K130450 | Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical GloveKGO · Traditional | Purna Bina Sdn Bhd | 09/30/2014SE |
| K141719 | Biogel PL Micro Surgical GloveKGO · Special | Molnlycke Health Care Us, LLC | 09/04/2014SE |
| K140988 | Powder Free Sterile Latex Surgical Glove, Yellow Color (Brand Name: Titanfine)KGO · Traditional | Hebei Hongsen Plastics Technology Co, Ltd. | 08/12/2014SE |
| K123126 | Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)KGO · Traditional | Shanghai Motex Healthcare Co., Ltd. | 06/04/2014SE |
| K132802 | Motex Powdered Nitrile Surgical GlovesKGO · Traditional | Shanghai Motex Healthcare Co., Ltd. | 05/21/2014SE |
| K122557 | Motex Powder-Free Nitrile Surgical GlovesKGO · Traditional | Shanghai Motex Healthcare Co., Ltd. | 10/03/2013SE |
| K131751 | Finessis Violet Element Polyisoprene Powderfree Sterile Surgical GlovesKGO · Traditional | Lucenxia Prescience AG | 09/25/2013SE |
| K121925 | Powdered Latex Surgeon's GloveKGO · Abbreviated | Suzhou Colour-Way Enterprise Development Co., Ltd. | 08/28/2013SE |
| K130301 | Latex Surgeon's Gloves (Powdered and Powder Free)KGO · Traditional | Elimedical Devices (Fujian), Inc. | 08/22/2013SE |
| K123629 | Finessis Polyisoprene Powderfree Surgical GlovesKGO · Traditional | Lucenxia Prescience AG | 05/13/2013SE |
| K123628 | Sterile Latex Surgical GloveKGO · Traditional | Lucenxia Prescience AG | 03/18/2013SE |
| K121335 | G-Derm Powder-Free Synthetic Surgical GloveKGO · Traditional | Hutchinson Sante S.N.C. | 09/13/2012SE |
| K121897 | Protexis Latex Basic Sterile Powder-Free Surgical GlovesKGO · Special | Cardinal Health, Inc. | 07/27/2012SE |
| K120934 | Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label…KGO · Traditional | Cardinal Health, Inc. | 05/23/2012SE |
| K113707 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingKGO · Traditional | Cardinal Health-Medical Products and Services | 04/27/2012SE |
| K113233 | Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling ClaimKGO · Traditional | Shen Wei (Usa), Inc. | 03/29/2012SE |
| K112654 | Powderfree Polyisoprene Surgical GlovesKGO · Traditional | Pt. Medisafe Technologies | 02/17/2012SE |
| K111413 | Biogel (R) Indicator (R) UndergloveKGO · Special | Molnlycke Health Care Us, LLC | 01/30/2012SE |
| K110698 | Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder FreeKGO · Traditional | Terang Nusa Sdn Bhd | 12/07/2011SE |
| K111878 | Protexis Latex Blue with Neu-Thera Powder-Free Surgical GlovesKGO · Traditional | Cardinal Health, Inc. | 09/29/2011SE |
| K111868 | Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient CoatingKGO · Traditional | Cardinal Health-Medical Products and Services | 09/21/2011SE |
| K112257 | Biogel Pi Orthopro Brown Surgical GloveKGO · Special | Molnlycke Health Care Us, LLC | 09/20/2011SE |
| K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UKGO · Traditional | Ansell Healthcare Products, Inc. | 09/02/2011SE |
| K112089 | Biogel Orthopor Brown Surgical GloveKGO · Special | Molnlycke Health Care Us, LLC | 08/24/2011SE |
| K111807 | Medline Powder-Free Latex Surgical Gloves, Sterile, W/ or W/O Aloe Vera, with Protein…KGO · Traditional | Medline Industries, Inc. | 08/18/2011SE |
| K103714 | Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with ChemotheraKGO · Traditional | Ansell Healthcare Products, LLC | 07/07/2011SE |
| K102177 | Sensicare Powder-Free Polymer Coated Polysoprene Surgical Gloves, SterileKGO · Abbreviated | Medline Industries, Inc. | 06/30/2011SE |
| K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugKGO · Traditional | Cardinal Health, Inc. | 06/08/2011SE |
| K111015 | Sterile Latex Powder Free Surgical Gloves with Hydrogel CoatingKGO · Traditional | Cardinal Health, Inc. | 05/06/2011SE |
| K101163 | Biogel Orthopro Indicator UndergloveKGO · Traditional | Molnlycke Health Care USA | 11/23/2010SE |
| K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingKGO · Traditional | Cardinal Health, Inc. | 11/04/2010SE |
| K101811 | Protegrity SMT Latex SurgicalglovesKGO · Traditional | Cardinal Health, Inc. | 10/15/2010SE |
| K102119 | Sur-G Glov and MaxitexKGO · Special | Terang Nusa Sdn Bhd | 08/27/2010SE |
| K101103 | Powdered, Natural Color, Latex Surgical Glove, Sterile Model: MSP1KGO · Traditional | Best Putra Gloves Sdn Bhd | 07/16/2010SE |
| K101102 | Powder-Free, Natural Color, Latex Surgical Glove, SterileKGO · Traditional | Best Putra Gloves Sdn Bhd | 07/16/2010SE |
| K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesKGO · Traditional | Cardinal Health, Inc. | 10/30/2009SE |
| K092304 | Esteem Ortho Polyisoprene Powder-Free Surgical GlovesKGO · Traditional | Cardinal Health, Inc. | 09/15/2009SE |
| K090066 | Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim…KGO · Traditional | Wear Safe (Malaysia) Sdn. Bhd. | 05/15/2009SE |
| K081180 | Skinsense Polyisoprene UndergloveKGO · Traditional | Molnlycke Health Care Us, LLC | 08/26/2008SE |
| K073447 | Surgi GlovesKGO · Traditional | Metacure Surgical Gloves Sdn Bhd | 04/24/2008SE |
| K071746 | Derma Prene Pi or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical…KGO · Traditional | Ansell Healthcare Products, LLC | 12/13/2007SE |
| K071700 | Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementKGO · Traditional | Molnlycke Health Care Us, LLC | 09/11/2007SE |
| K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementKGO · Traditional | Molnlycke Health Care Us, LLC | 09/11/2007SE |
| K071565 | Biogel Indicator Underglove with Non-Pyrogenic StatementKGO · Traditional | Molnlycke Health Care Us, LLC | 09/10/2007SE |
| K071414 | Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling…KGO · Traditional | Molnlycke Health Care Us, LLC | 09/10/2007SE |
| K063757 | Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesKGO · Traditional | Shanghai Motex Healthcare Co., Ltd. | 07/27/2007SE |
| K070619 | Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile, Coated with Aloe Vera…KGO · Special | Wrp Asia Pacific Sdn. Bhd. | 06/27/2007SE |
| K070647 | Triflex SelectKGO · Special | Cardinal Health, Inc. | 06/22/2007SE |
| K063582 | Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeKGO · Traditional | Zimmer, Inc. | 04/26/2007SE |
| K062797 | Powdered Latex Surgical GloveKGO · Abbreviated | Beijing Reagent Latex Products Co., Ltd. | 04/11/2007SE |
| K062950 | Powder Free Sterile Nitrile Surgical Gloves (Blue)KGO · Traditional | Hartalega Sdn Bhd | 12/21/2006SE |
| K062847 | Biogel Eclipse Indicator UndergloveKGO · Traditional | Molnlycke Health Care Us, LLC | 12/20/2006SE |
| K053406 | Barrierplus Gold Powder-Free Synthetic Polyisoprene Surgical GlovesKGO · Traditional | Barriermed Glove Co. | 07/05/2006SE |
| K060030 | The Double GloveKGO · Traditional | Biobarrier, Inc. | 06/27/2006SE |
| K061038 | Barrierplus Platinum Powder-Free Synthetic Polychloroprene Surgical Gloves, Models…KGO · Traditional | Barriermed Glove Co. | 06/23/2006SE |
| K053441 | Biogel Latex Powder Free Sterile Surgeon's GloveKGO · Traditional | Regent Medical Americas, LLC | 04/10/2006SE |
| K053102 | Biogel Skinsense Powder-Free Non-Latex Surgeon's GloveKGO · Traditional | Regent Medical Americas, LLC | 03/10/2006SE |
| K053442 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveKGO · Traditional | Regent Medical Americas, LLC | 03/07/2006SE |
| K053443 | Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's GloveKGO · Traditional | Regent Medical Americas, LLC | 02/01/2006SE |
| K053272 | Cardinal Health Protegrity Blue with Neu-Thera Surgical GlovesKGO · Special | Cardinalhealth | 01/05/2006SE |
| K052772 | Barrierplus Gold Ortho Powder-Free Synthetic Polyisoprene Orthopedic Surgical GlovesKGO · Traditional | Barriermed Glove Co. | 12/20/2005SE |
| K052177 | Powder Free Sterile Latex Surgical GlovesKGO · Traditional | Hartalega Sdn Bhd | 12/09/2005SE |
| K052837 | Sensiflex Plus Polymer Coated Latex Powder-Free Surgical Glove with Aloe VeraKGO · Special | Terang Nusa Sdn Bhd | 11/21/2005SE |
| K051562 | Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…KGO · Traditional | Terang Nusa Sdn Bhd | 10/20/2005SE |
| K052030 | Surgeon's Glove, Powder FreeKGO · Traditional | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 09/13/2005SE |
| K052031 | Powdered Latex Surgeon's GloveKGO · Traditional | Shun Thai Rubber Gloves Industry Public Co., Ltd. | 09/12/2005SE |
| K051793 | Encore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing…KGO · Traditional | Ansell Healthcare Products, LLC | 08/17/2005SE |
| K050899 | Biogel Latex Sterile Powder-Free GloveKGO · Traditional | Regent Medical Americas, LLC | 08/12/2005SE |
| K051563 | Nuzone X2A Neoprene - Polyisoprene Powder Free Surgical Gloves Polymer and Aloe CoatedKGO · Special | Terang Nusa Sdn Bhd | 06/20/2005SE |
| K051094 | Nuzone X2T Polychloroprene Synthetic Tan Surgical Glove - PowderfreeKGO · Special | Terang Nusa Sdn Bhd | 06/06/2005SE |
| K050071 | Medispo (Powdered) and Medispo-Pf (Powder-Free) Surgeons GloveKGO · Traditional | H.B.M. USA Co.,Inc. | 05/11/2005SE |
| K042534 | Marina Medical Finger ProtectorsKGO · Traditional | Marina Medical Instruments, Inc. | 05/10/2005SE |
| K050533 | Eclipse Latex Powder Free Sterile Surgeon's GloveKGO · Traditional | Regent Medical Americas, LLC | 04/26/2005SE |
| K050181 | Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical GlovesKGO · Abbreviated | Medigloves , Ltd. | 04/13/2005SE |
| K050184 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveKGO · Traditional | Regent Medical Americas, LLC | 03/16/2005SE |
| K043508 | Derma Prene Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use)KGO · Traditional | Ansell Healthcare Products, LLC | 01/19/2005SE |
| K042567 | Powderfree Polychloroprene Sterilized Surgical Gloves with Aloe Vera and Vitamin EKGO · Traditional | Pt. Medisafe Technologies | 01/13/2005SE |
| K042574 | Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin…KGO · Traditional | Cardinalhealth | 12/08/2004SE |
| K041437 | Maxitex Latex Neuro PF Surgical Glove PowderfreeKGO · Traditional | Terang Nusa Sdn Bhd | 09/16/2004SE |
| K041436 | Synthetic Surgical Glove-Powderfree Nuzone X2KGO · Traditional | Terang Nusa Sdn Bhd | 08/20/2004SE |
| K031368 | Powdered Latex Surgeon's GlovesKGO · Traditional | Cephas Medical Private , Ltd. | 06/22/2004SE |
| K033905 | Protegrity Steile Latex Surgical Gloves with CoatingKGO · Traditional | Cardinalhealth | 04/27/2004SE |
| K040503 | Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with…KGO · Special | Wrp Asia Pacific Sdn. Bhd. | 03/16/2004SE |
| K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of…KGO · Traditional | Kanam Latex Industries Pvt. , Ltd. | 02/24/2004SE |
| K032942 | Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, SterileKGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 12/17/2003SE |
| K032647 | Aloetouch Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Colour and Coated…KGO · Traditional | Wrp Asia Pacific Sdn. Bhd. | 11/07/2003SE |
| K023139 | Romed Latex Surgical Gloves, Powdered, SterileKGO · Traditional | Van Oostveen Medical B.V. | 10/22/2003SE |
| K032501 | Maxter Sterile Powder Free Surgical GlovesKGO · Traditional | Maxter Glove Manufacturing Sdn Bhd | 10/17/2003SE |
| K031301 | Esteem Sterile Polyisoprene Surgical Gloves with CoatingKGO · Traditional | Cardinalhealth | 10/15/2003SE |
| K032467 | Maxter Sterile Powdered Latex Surgical GlovesKGO · Traditional | Maxter Glove Manufacturing Sdn Bhd | 10/10/2003SE |
| K031670 | Sterile Powder Free Latex Surgical Glove with Polymer CoatingKGO · Traditional | P.T. Saptindo Surgica | 09/23/2003SE |
| K031669 | Sterile Powder Free Synthetic Surgical Glove with Polymer CoatingKGO · Traditional | P.T. Saptindo Surgica | 09/23/2003SE |
| K032464 | Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with…KGO · Special | Wrp Asia Pacific Sdn. Bhd. | 08/22/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1725-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-0097-2024 Class II | NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290Some surgical glove sterile pouches were not completely sealed. | Ansell Healthcare Products LLC | 08/03/2023Open, Classified |
| Z-0096-2024 Class II | GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290Some surgical glove sterile pouches were not completely sealed. | Ansell Healthcare Products LLC | 08/03/2023Open, Classified |
| Z-0902-2022 Class II | Cardinal Health PROTEXIS PI and PI Classic, Surgical GlovesProduct was distributed without being sterilized. | Cardinal Health 200, LLC | 03/15/2022Completed |
| Z-0838-2022 Class II | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical…Transport company failed to stop at the border for required FDA inspection. | Ansell Healthcare Products LLC | 02/19/2022Open, Classified |
| Z-2919-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2918-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2917-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2916-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2915-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2914-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2913-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-2912-2020 Class II | PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a…A degradation defect was found that could lead to holes and donning tears at the folding area around the… | Cardinal Health 200, LLC | 07/29/2020Completed |
| Z-0638-2019 Class II | Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0637-2019 Class II | Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0636-2019 Class II | Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0635-2019 Class II | Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0634-2019 Class II | Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0633-2019 Class II | Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0632-2019 Class II | Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-0631-2019 Class II | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored…Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and… | Cardinal Health 200, LLC | 10/31/2018Terminated |
| Z-2036-2018 Class II | AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No.…Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S.… | WRP Asia Pacific Sdn Bhd | 05/07/2018Terminated |
| Z-0162-2018 Class II | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with…Possible open seal on top portion of the package. Could cause breach of sterility. | Medline Industries Inc | 10/23/2017Terminated |
| Z-0456-2019 Class II | Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical…Powdered Surgical Gloves are an FDA banned substance. | American Contract Systems, Inc. | 12/28/2016Terminated |
| Z-0893-2017 Class II | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama…Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive… | Ansell Healthcare Products LLC | 10/24/2016Terminated |
| Z-0621-2011 | ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R…open package seams on sterile gloves | Ansell Healthcare Products LLC | 09/03/2010Terminated |
| Z-1589-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1588-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1587-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1586-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1585-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1584-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1583-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4…Premature degradation which could result in tearing during use. | Ansell Healthcare Products LLC | 05/01/2009Terminated |
| Z-1452-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1451-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1450-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1449-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1448-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1447-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1446-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-1445-2009 | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic…Increase in the number of customer complaints due to cuff tears. | Cardinal Health | 04/24/2009Terminated |
| Z-0365-2007 | Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain…Some of the packages labeled as latex-free actually contain latex gloves. | Terang Nusa Sdn Bhd | 12/18/2006Terminated |