Cleared Traditional

K935866 - COMFIT POWERED EXAMINATION GLOVES(BEADED

K935866 is an FDA 510(k) clearance for COMFIT POWERED EXAMINATION GLOVES(BEADED, 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 166-day FDA review.

K935866 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Optimized for regulatory review, auditing and printing
May 1994
Decision
166d
Days
Class 1
Risk

K935866 is an FDA 510(k) clearance for the COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Malaysia, MY). The FDA issued a Cleared decision on May 18, 1994 after a review of 166 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 - K935866

510(k) Number K935866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date May 18, 1994
Days to Decision 166 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
37d slower than avg
Panel avg: 129d · This submission: 166d
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 K935866.
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24
K936062 · Hartalega Sdn Bhd · Jun 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
K936063 · Hartalega Sdn Bhd · Jun 1994
LATEX PATIENT EXAMINATION GLOVE
K940022 · Siam Sempermed Corp., Ltd. · May 1994
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · Wembley Rubber Products (M) Sdn Bhd · May 1994
POWDER-FREE LATEX EXAMINATION GLOVES
K935812 · Shen Wei (Usa), Inc. · Mar 1994
COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC)
K935852 · Wembley Rubber Products (M) Sdn Bhd · Mar 1994