Hpi Sensi Grip Sterile Powdered Latex Surgical Glove,with Labeled Protein Content and Made from Allotex an Enzyme Treat
K013324 is the FDA 510(k) clearance record for HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT, a class I device, cleared for Tillotson Healthcare Corp. 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 20 510(k) clearances for Tillotson Healthcare Corp., from to . As of , FDA records show no recalls naming K013324.
Clearance record
- Decision date
- Received
- (55 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Tillotson Healthcare Corp. 360 Rte. 101 W, Bedford NH
- 510(k) summary
- Summary
- 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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