Cleared Traditional

K922379 - STERILE LATEX EXAMINATION GLOVES

K922379 is an FDA 510(k) clearance for STERILE LATEX EXAMINATION GLOVES, manufactured by Smith & Nephew Perry. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K922379 · Smith & Nephew Perry · General Hospital
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Sep 1992
Decision
125d
Days
Class 1
Risk

K922379 is an FDA 510(k) clearance for the STERILE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Smith & Nephew Perry (Massillon, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Smith & Nephew Perry devices

FDA 510(k) Submission Details - K922379

510(k) Number K922379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date September 22, 1992
Days to Decision 125 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
4d faster than avg
Panel avg: 129d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - LYY Latex Patient Examination Glove

All 270
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K922379.
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · Siam Sempermed Corp., Ltd. · Feb 1993
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · Wembley Rubber Products (M) Sdn Bhd · Aug 1992
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992