Powdered Latex Surgeon's Glove
K052031 is the FDA 510(k) clearance record for POWDERED LATEX SURGEON'S GLOVE, a class I device, cleared for Shun Thai Rubber Gloves Industry Public Co., Ltd. on under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "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...". FDA records list 6 510(k) clearances for Shun Thai Rubber Gloves Industry Public Co., Ltd., from to . As of , FDA records show no recalls naming K052031.
Clearance record
- Decision date
- Received
- (47 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Shun Thai Rubber Gloves Industry Public Co., Ltd. 198 Ave. De La D'Emerald, Sparks NV
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code KGO
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
