Cleared Traditional

NYLON LINER GLOVES (K940274) - FDA 510(k) Clearance

Class I General Hospital device.

K940274 · Wells Lamont Corp. · General Hospital
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May 1994
Decision
111d
Days
Class 1
Risk

K940274 is an FDA 510(k) clearance for the NYLON LINER GLOVES. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Wells Lamont Corp. (Niles, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 111 days - within the typical 510(k) review window.

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 Wells Lamont Corp. devices

Submission Details

510(k) Number K940274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date May 12, 1994
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
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.