Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
FDA 510(k) K142941 · Pt. Medisafe Technologies
510(k) numberK142941
Submission
- Device name
- Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
- Applicant
- Pt. Medisafe Technologies
Tanjung Morawa, Medan, ID - Received
- October 9, 2014
- Decision date
- November 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGO – Surgeon'S Gloves
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4460
- Specialty
- 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.
Other 510(k)s with product code KGO
| 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 |
More from Wrp Asia Pacific Sdn. Bhd.
| 510(k) | Device | Decision |
|---|---|---|
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested…KGO · Traditional | 09/16/2020SE |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with…KGO · Traditional | 03/28/2019SE |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with…KGO · Traditional | 04/20/2018SE |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin ELZA · Traditional | 02/22/2017SE |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy…KGO · Traditional | 07/14/2015SE |
| K133689 | Powder Free Polychloroprene Light Wieght Examinationgloves- Green,Blue and PinkLZA · Traditional | 07/03/2014SE |
| K112654 | Powderfree Polyisoprene Surgical GlovesKGO · Traditional | 02/17/2012SE |
| K102623 | Blue Powderfree Nitrile Examination GloveLZA · Traditional | 06/06/2011SE |
| K102620 | Powderfree Black Nitrile Examination GlovesLZA · Traditional | 11/22/2010SE |
| K082302 | Powder Free Nitrile Patient Examination Gloves with Chemo Labeling ClaimLZA · Traditional | 12/09/2008SE |
Questions and answers
When was Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. cleared by the FDA?
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. (K142941) received a 510(k) decision of Substantially Equivalent on November 2, 2015, 389 days after the submission was received.
What is the product code of K142941?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.