Cleared Traditional

K925628 - ULTRATUFF CUT RESISTANT GLOVE LINER (FDA 510(k) Clearance)

Class I General Hospital device.

K925628 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (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.

View all Baxter Healthcare Corp devices

Submission Details

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
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 128d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.