Cleared Traditional

K925628 - ULTRATUFF CUT RESISTANT GLOVE LINER

K925628 is an FDA 510(k) clearance for ULTRATUFF CUT RESISTANT GLOVE LINER, manufactured by Baxter Healthcare Corp. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K925628 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
245d
Days
Class 1
Risk

K925628 is an FDA 510(k) clearance for the ULTRATUFF CUT RESISTANT GLOVE LINER. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K925628

510(k) Number K925628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date July 09, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 55
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K925628.
ISOLAIR 2 FULL FACE SPLASH GUARD
K931288 · Louis M. Gerson Co., Inc. · Jan 1994
ACTION MEDTEK FACE SHIELD
K926438 · Action Eyewear Corp. · Aug 1993
CATALOG NUMBER 111 (FACESHIELD)
K925290 · Ansley Medical Products, Inc. · Jul 1993
WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
K922407 · Wells Lamont Corp. · Jun 1993
MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
K923229 · Medical Armor Corp. · May 1993
GUARDALL SHIELD
K915415 · Anago, Inc. · Oct 1992
K925628 · ULTRATUFF CUT RESISTANT GLOVE LINER
Download PDF FDA Summary Baxter Healthcare Corp