510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953015Substantially Equivalent

Safeskin Supra

Safeskin Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953015 is the FDA 510(k) clearance record for SAFESKIN SUPRA, a class I device, cleared for Safeskin 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 24 510(k) clearances for Safeskin Corp., from to . As of , FDA records show no recalls naming K953015.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Safeskin Corp. 6815 Flanders Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code KGO

Trailing 12 months
2 clearances under product code KGO in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260