510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053441Substantially Equivalent

Biogel Latex Powder Free Sterile Surgeon's Glove

Regent Medical Americas, LLC, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053441 is the FDA 510(k) clearance record for BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE, a class I device, cleared for Regent Medical Americas, LLC 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 7 510(k) clearances for Regent Medical Americas, LLC, from to . As of , FDA records show no recalls naming K053441.

Clearance record

Decision date
Received
(122 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Regent Medical Americas, LLC 3585 Engineering Dr., Suite 250, Norcross GA
510(k) summary
Summary PDF
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