Cleared Traditional

K953213 - COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)

K953213 is an FDA 510(k) clearance for COMFIT (POWDER FREE 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 459-day FDA review.

K953213 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
459d
Days
Class 1
Risk

K953213 is an FDA 510(k) clearance for the COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED). 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 October 11, 1996 after a review of 459 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 (M) Sdn Bhd devices

FDA 510(k) Submission Details - K953213

510(k) Number K953213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date October 11, 1996
Days to Decision 459 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
330d slower than avg
Panel avg: 129d · This submission: 459d
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 912
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K953213.
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096 · Medline Industries, Inc. · Nov 1996
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
K960590 · Aladan Corp. · Oct 1996
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K963560 · Pwa Industries Sdn. Bhd. · Oct 1996
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K954416 · Hartalega Sdn Bhd · Oct 1996
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
K961415 · Siam Sempermed Corp., Ltd. · Oct 1996
LATEX PATIENT EXAMINATION GLOVE (PINK)
K961602 · Siam Sempermed Corp., Ltd. · Oct 1996