Cleared Traditional

K943601 - COMFIT (PINK)

K943601 is an FDA 510(k) clearance for COMFIT (PINK), 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 296-day FDA review.

K943601 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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May 1995
Decision
296d
Days
Class 1
Risk

K943601 is an FDA 510(k) clearance for the COMFIT (PINK). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Sepang Selangor, MY). The FDA issued a Cleared decision on May 17, 1995 after a review of 296 days - an extended review 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: 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 - K943601

510(k) Number K943601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date May 17, 1995
Days to Decision 296 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
167d slower than avg
Panel avg: 129d · This submission: 296d
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 K943601.
HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945766 · Ansell, Inc. · Aug 1995
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · Cypress Medical Products, Ltd. · Jul 1995
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
K946257 · Siam Sempermed Corp., Ltd. · Jun 1995
COMFIT/GREEN POWDERED EXAMINATION GLOVES
K951667 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX/POWDER FREE EXAMINATION GLOVES
K951668 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX
K945785 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995