Cleared Traditional

K935812 - POWDER-FREE LATEX EXAMINATION GLOVES

K935812 is an FDA 510(k) clearance for POWDER-FREE LATEX EXAMINATION GLOVES, manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K935812 · Shen Wei (Usa), Inc. · General Hospital
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Mar 1994
Decision
111d
Days
Class 1
Risk

K935812 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Foster City, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 111 days - within the typical 510(k) review window.

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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K935812

510(k) Number K935812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date March 23, 1994
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
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 638
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K935812.
COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)
K935866 · Wembley Rubber Products (M) Sdn Bhd · May 1994
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · Wembley Rubber Products (M) Sdn Bhd · May 1994
SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE
K940873 · Aladan Corp. · Apr 1994
COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC)
K935852 · Wembley Rubber Products (M) Sdn Bhd · Mar 1994
COMFIT
K933263 · Wembley Rubber Products (M) Sdn Bhd · Feb 1994
COMFIT GREEN POWDER FREE EXAMINATION GLOVE
K934812 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994