510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925628Substantially Equivalent

Ultratuff Cut Resistant Glove Liner

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925628 is the FDA 510(k) clearance record for ULTRATUFF CUT RESISTANT GLOVE LINER, a class I device, cleared for Baxter Healthcare Corp on under FDA product code LYU (Accessory, Surgical Apparel). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K925628.

Clearance record

Decision date
Received
(245 days to decision)
Product code
LYU Accessory, Surgical Apparel
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
510(k) summary
Summary
Third party review
No

Clearances, product code LYU

Trailing 12 months

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

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