510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000971Substantially Equivalent

Profeel Powder Free Nitrile Surgical Glove, Sterile

WRP Asia Pacific Sdn Bhd, Salak Tinggi, Sepang Selangor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000971 is the FDA 510(k) clearance record for PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE, a class I device, cleared for Wrp Asia Pacific Sdn. Bhd. 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 46 510(k) clearances for Wrp Asia Pacific Sdn. Bhd., from to . As of , FDA records show no recalls naming K000971.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Wrp Asia Pacific Sdn. Bhd. Lot 1, Jalan 3,, Salak Tinggi, Sepang Selangor, MY
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