KGO · Surgeon'S Gloves
General, Plastic Surgery · 21 CFR 878.4460 · Class 1
Overview
| Product Code | KGO |
|---|---|
| Device Name | Surgeon'S Gloves |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (20 of 558)
Showing 20 most recent of 558 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | Aug 19, 2025 | SESE |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | Aug 23, 2024 | SESE |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | Mar 28, 2024 | SESE |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | Dec 20, 2023 | SESE |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Ansell Healthcare | Oct 20, 2023 | SESE |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | Sep 29, 2023 | SESE |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | Sep 22, 2023 | SESE |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | Aug 31, 2023 | SESE |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC | Aug 23, 2023 | SESE |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd | Aug 18, 2023 | SESE |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | Aug 16, 2023 | SESE |
| K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | Aug 9, 2023 | SESE |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | May 26, 2023 | SESE |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | May 13, 2023 | SESE |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Apr 13, 2023 | SESE |
| K222620 | Sterilized Latex Surgical Gloves | Suzhou Colour-Way New Material Co., Ltd. | Mar 23, 2023 | SESE |
| K221424 | Sterile Surgical Powder Free Latex Glove | New Era Medicare Sdn. Bhd. | Jan 26, 2023 | SESE |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | Wrp Asia Pacific Sdn. Bhd. | Oct 22, 2022 | SESE |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | Hartalega NGC Sdn. Bhd. | Sep 24, 2022 | SESE |
| K221748 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | Sep 13, 2022 | SESE |
Top Applicants
- Wrp Asia Pacific Sdn. Bhd. — 20 clearances
- Molnlycke Health Care Us, LLC — 16 clearances
- Wembley Rubber Products (M) Sdn Bhd — 15 clearances
- Terang Nusa Sdn Bhd — 15 clearances
- Ansell Perry — 15 clearances
