510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910941Substantially Equivalent

Lifeliner Surgical Glove

Depuy-Raynham, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910941 is the FDA 510(k) clearance record for LIFELINER SURGICAL GLOVE, a class I device, cleared for Depuy-Raynham on under FDA product code FYE (Dress, Surgical). FDA records list 3 510(k) clearances for Depuy-Raynham, from to . As of , FDA records show no recalls naming K910941.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FYE Dress, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Depuy-Raynham P.O. Box 988, Warsaw IN
Third party review
No

Clearances, product code FYE

Trailing 12 months

FDA records hold no clearances under product code FYE in the trailing twelve months.

FDA records show no clearances under product code FYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260