Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
K190632 is the FDA 510(k) clearance record for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein, a class I device, cleared for Lenora Glove Pvt , 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 one 510(k) clearance for Lenora Glove Pvt , Ltd. As of , FDA records show no recalls naming K190632.
Clearance record
- Decision date
- Received
- (226 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Lenora Glove Pvt , Ltd. Plot No: 15/104-1, Rottigoundanur, Thirumalayampalayam P.O., Coimbatore, IN
- 510(k) summary
- Summary PDF
- 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 |
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