Cleared Traditional

K903746 - COMFIT

K903746 is an FDA 510(k) clearance for COMFIT, manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K903746 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Sep 1990
Decision
23d
Days
Class 1
Risk

K903746 is an FDA 510(k) clearance for the COMFIT, PATIENT EXAMINATION GLOVES. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Kuala Lumpur, Malaysia, MY). The FDA issued a Cleared decision on September 5, 1990 after a review of 23 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 - K903746

510(k) Number K903746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date September 05, 1990
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 14
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K903746.
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404 · Safeskin Corp. · May 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405 · Safeskin Corp. · May 1994
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175 · Ulti-Med Intl., Inc. · Jun 1993
ROCKET SEX CRIME KIT
K883805 · A & A Medical, Inc. · Jan 1989
ORTHOPEDIC SURGICAL GLOVE
K831564 · Ansell, Inc. · Jul 1983
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982