KGO — Surgeon'S Gloves Class I
Classification Details
- Product Code
- KGO
- Device Class
- Class I
- Regulation Number
- 878.4460
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250313 | harps europe manufacturing | Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For U | August 19, 2025 |
| K240790 | suzhou colour-way new material co | Polyisoprene Surgical gloves | August 23, 2024 |
| K232079 | wrp asia pacific sdn. bhd | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with C | March 28, 2024 |
| K232444 | grand work plastic products co | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drug | December 20, 2023 |
| K231902 | ansell healthcare | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX P | October 20, 2023 |
| K231973 | ineo tech | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | September 29, 2023 |
| K231446 | fitone latex products co., ltd. guangdong | Single-Use Latex Sterile Surgical Gloves (SG100) | September 22, 2023 |
| K230578 | wrp asia pacific sdn. bhd | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with | August 31, 2023 |
| K230079 | ansell healthcare products | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm | August 23, 2023 |
| K222993 | sentienx | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green | August 18, 2023 |
| K230832 | egyptian company for medical and electronic industries | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | August 16, 2023 |
| K230304 | puyang linshi medical supplies co | Polyisoprene Surgical Gloves | August 9, 2023 |
| K213289 | ansell healthcare products | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | May 26, 2023 |
| K230217 | grand work plastic products co | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherap | May 13, 2023 |
| K222350 | jr engineering and medical technologies (m) sdn. bhd | Sterile Nitrile Surgical Gloves Powder Free | April 13, 2023 |
| K222620 | suzhou colour-way new material co | Sterilized Latex Surgical Gloves | March 23, 2023 |
| K221424 | new era medicare sdn. bhd | Sterile Surgical Powder Free Latex Glove | January 26, 2023 |
| K222058 | wrp asia pacific sdn. bhd | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemother | October 22, 2022 |
| K221718 | hartalega ngc sdn. bhd | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs ( | September 24, 2022 |
| K221748 | guilin hbm health protections | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | September 13, 2022 |