Gammex PI Hybrid Surgical Gloves
FDA 510(k) K151694 · Ansell Healthcare Products, LLC
510(k) numberK151694
Submission
- Device name
- Gammex PI Hybrid Surgical Gloves
- Applicant
- Ansell Healthcare Products, LLC
Iselin, NJ, US - Received
- June 23, 2015
- Decision date
- March 9, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…KGO · Traditional | 08/23/2023SE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy DrugsKGO · Traditional | 05/26/2023SE |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…LZA · Traditional | 03/10/2022SE |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…LZA · Traditional | 06/13/2021SE |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…LZA · Traditional | 06/19/2020SE |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…KGO · Traditional | 05/23/2019SE |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsKGO · Traditional | 03/22/2019SE |
| K171375 | Gammex PI Breach Detect Powder Free Surgical GloveKGO · Traditional | 02/06/2018SE |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesLZA · Traditional | 12/29/2017SE |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOL · Abbreviated | 08/02/2017SE |
Questions and answers
When was Gammex PI Hybrid Surgical Gloves cleared by the FDA?
Gammex PI Hybrid Surgical Gloves (K151694) received a 510(k) decision of Substantially Equivalent on March 9, 2016, 260 days after the submission was received.
What is the product code of K151694?
The FDA product code is KGO – Surgeon'S Gloves, a Class I (low risk) device regulated under 21 CFR 878.4460.