Cleared Traditional

K962189 - COMFIT POWDER FREE GREEN EXAMINATION GL...

K962189 is an FDA 510(k) clearance for COMFIT POWDER FREE GREEN EXAMINATION GL..., 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 50-day FDA review.

K962189 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
50d
Days
Class 1
Risk

K962189 is an FDA 510(k) clearance for the COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on July 26, 1996 after a review of 50 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 - K962189

510(k) Number K962189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date July 26, 1996
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K962189.
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES
K960225 · Tillotson Healthcare Corp. · Jul 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · Tillotson Healthcare Corp. · Jul 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT
K953590 · Wembley Rubber Products (M) Sdn Bhd · Jun 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467 · Biopro, Inc. · May 1996
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221 · Hartalega Sdn Bhd · May 1996