510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K944873Substantially Equivalent

Triflex Non-Sterile Synthitic Examination Gloves

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944873 is the FDA 510(k) clearance record for TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES, a class I device, cleared for Baxter Healthcare Corp on under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K944873.

Clearance record

Decision date
Received
(179 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Baxter Healthcare Corp 1500 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code LYZ

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