Cleared Traditional

K922513 - COMFIT STERILE LATEX EXAMINATION GLOVE

K922513 is an FDA 510(k) clearance for COMFIT STERILE LATEX EXAMINATION GLOVE, manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K922513 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Aug 1992
Decision
85d
Days
Class 1
Risk

K922513 is an FDA 510(k) clearance for the COMFIT STERILE LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Kuala Lumpur, Malaysia, MY). The FDA issued a Cleared decision on August 20, 1992 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K922513

510(k) Number K922513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date August 20, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 319
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K922513.
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
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K912988 · La Glove (M) Sdn. Bhd. · Aug 1991