Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.p. Less Than 50 Ug/dm2
K033564 is the FDA 510(k) clearance record for POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2, a class I device, cleared for Kanam Latex Industries 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 5 510(k) clearances for Kanam Latex Industries Pvt. , Ltd., from to . As of , FDA records show no recalls naming K033564.
Clearance record
- Decision date
- Received
- (104 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Kanam Latex Industries Pvt. , Ltd. Oppoottil Bldg., Kottayam, Kerala, IN
- 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 |
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