Cleared Traditional

K936295 - COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)

K936295 is an FDA 510(k) clearance for COMFIT BLUE POWERED EXAMINATION GLOVES ..., manufactured by Wembley Rubber Products. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K936295 · Wembley Rubber Products · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
424d
Days
Class 1
Risk

K936295 is an FDA 510(k) clearance for the COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (Malaysia, MY). The FDA issued a Cleared decision on February 24, 1995 after a review of 424 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Wembley Rubber Products devices

FDA 510(k) Submission Details - K936295

510(k) Number K936295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date February 24, 1995
Days to Decision 424 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
295d slower than avg
Panel avg: 129d · This submission: 424d
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 709
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K936295.
PATIENT EXAMINATION GLOVES
K945885 · Hartalega Sdn Bhd · Mar 1995
COMFIT BLUE POWDER FREE EXAMINATION GLOVES
K943563 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995
POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945767 · Ansell, Inc. · Mar 1995
ULTIMAX POWDER FREE EXAMINATION GLOVES
K943451 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511 · Wembley Rubber Products (M) Sdn Bhd · Feb 1995