Cleared Traditional

K902633 - CUT RESISTANT GLOVE LINER

K902633 is an FDA 510(k) clearance for CUT RESISTANT GLOVE LINER, manufactured by Biomet, Inc.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K902633 · Biomet, Inc. · General Hospital
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Jul 1990
Decision
43d
Days
Class 1
Risk

K902633 is an FDA 510(k) clearance for the CUT RESISTANT GLOVE LINER. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K902633

510(k) Number K902633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date July 27, 1990
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K902633.
OP-D-OP VISOR SHIELDS
K911742 · Op-D-Op, Inc. · Jun 1991
PARADERM(TM) SURGEON'S GLOVE ACCESSORY
K904903 · Lovell-Schenck, Inc. · Jan 1991
SURGICAL COTTON GLOVES
K900425 · Allo Pro Corp. · Sep 1990
PHYSICIAN BARRIER GLOVE, SURGICAL
K901221 · Dynamic Marketing Ent. · Jul 1990
MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE
K902016 · Aor-Sullivan · May 1990
REPEL SURGICAL GLOVE LINERS
K900310 · Depuy-Raynham · Mar 1990
K902633 · CUT RESISTANT GLOVE LINER
Download PDF Biomet, Inc.