KGO
- Product code
- KGO
- Device name
- Surgeon'S Gloves
- Device class
- Class 1
- 21 CFR
- 21 CFR 878.4460
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 560
FDA classification 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.
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260558 | 2026-07-28 | Hartalega NGC Sdn. Bhd. | Latex Powder Free Surgical Gloves Tested for Use wit | |
| K253060 | 2026-05-22 | Protect Gloves Company Limited | Sterile Latex Powder Free Surgical Gloves | |
| K250313 | 2025-08-19 | Harps Europe Manufacturing GmbH | Sterile Powder Free Synthetic Rubber Surgeons Glove | |
| K240790 | 2024-08-23 | Suzhou Colour-Way New Material Co., Lt | Polyisoprene Surgical gloves | — |
| K232079 | 2024-03-28 | Wrp Asia Pacific Sdn. Bhd. | Natural Rubber Latex Surgical Glove, Powder Free, St | |
| K232444 | 2023-12-20 | Grand Work Plastic Products Co., Ltd. | Sterile Powder Free Latex Surgical Gloves, Tested fo | |
| K231902 | 2023-10-20 | Ansell Healthcare | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid | FDA |
| K231973 | 2023-09-29 | Ineo Tech Sdn Bhd | PolyIsoprene Powder Free Black Colour Radiation Atte | FDA |
| K231446 | 2023-09-22 | Fitone Latex Products Co., Ltd. Guangd | Single-Use Latex Sterile Surgical Gloves (SG100) |
Official FDA classification page: KGO
Classification and pathway per current FDA publications. Data from openFDA (CC0).