Cleared Traditional

K934813 - COMFIT BLUE POWDER FREE EXAMINATION GLOVE

K934813 is an FDA 510(k) clearance for COMFIT BLUE POWDER FREE 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 92-day FDA review.

K934813 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Jan 1994
Decision
92d
Days
Class 1
Risk

K934813 is an FDA 510(k) clearance for the COMFIT BLUE POWDER FREE 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 January 7, 1994 after a review of 92 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 Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K934813

510(k) Number K934813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1993
Decision Date January 07, 1994
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 912
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K934813.
POWDER FREE LATEX EXAMINATION GLOVES
K934345 · Vas Latex Co. , Ltd. · Jan 1994
POWDER-FREE LATEX EXAMINATION GLOVE
K934546 · Powercrest (M) Sdn. Bhd. · Jan 1994
COMFIT GREEN POWDER FREE EXAMINATION GLOVE
K934812 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
PATIENT EXAMINATION GLOVE
K934942 · P.T. Surya Milani Plastic Utama · Jan 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K924906 · Jentera Jaya Sdn Bhd · Dec 1993
ROYAL SHIELD SHIELD GLOVES
K926132 · Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · Dec 1993