510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912797Substantially Equivalent

Perry Natural Powder Free Gloves

Smith & Nephew, Inc., Massillon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912797 is the FDA 510(k) clearance record for PERRY NATURAL POWDER FREE GLOVES, a class I device, cleared for Smith & Nephew, Inc. 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 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K912797.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Smith & Nephew, Inc. 1875 Harsh Ave. SE, Massillon OH
510(k) summary
Statement
Third party review
No

Clearances, product code KGO

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