Cleared Traditional

K900425 - SURGICAL COTTON GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

K900425 · Allo Pro Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
220d
Days
Class 1
Risk

K900425 is an FDA 510(k) clearance for the SURGICAL COTTON GLOVES. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Allo Pro Corp. (Clearwater, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 220 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 Allo Pro Corp. devices

Submission Details

510(k) Number K900425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date September 07, 1990
Days to Decision 220 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 128d · This submission: 220d
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.