Cleared Traditional

K936268 - COMFIT BLUE POWDERED EXAMINATION GLOVES

K936268 is an FDA 510(k) clearance for COMFIT BLUE POWDERED EXAMINATION GLOVES, 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 342-day FDA review.

K936268 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Dec 1994
Decision
342d
Days
Class 1
Risk

K936268 is an FDA 510(k) clearance for the COMFIT BLUE POWDERED EXAMINATION GLOVES. 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 December 7, 1994 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K936268

510(k) Number K936268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date December 07, 1994
Days to Decision 342 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
213d slower than avg
Panel avg: 129d · This submission: 342d
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 K936268.
SCIPOTEX
K943868 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · Sri Johani Sdn. Bhd. · Jan 1995
LATEX MEDICAL GLOVE
K943900 · Johnson & Johnson Medical, Inc. · Dec 1994
COMFIT
K944140 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K942947 · Wembley Rubber Products (M) Sdn Bhd · Nov 1994
LATEX EXAMINATION GLOVES
K943707 · Arista Latindo Industrial Ltd. P.T · Nov 1994