Cleared Traditional

K934133 - PATIENT EXAMINATION GLOVES (POWDER FREE...

K934133 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (POWDER FREE..., manufactured by Supergrade Healthcare Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K934133 · Supergrade Healthcare Products Sdn. Bhd. · General Hospital
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Jan 1994
Decision
142d
Days
Class 1
Risk

K934133 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Supergrade Healthcare Products Sdn. Bhd. (10050 Penang, Malaysia, ML). The FDA issued a Cleared decision on January 7, 1994 after a review of 142 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 Supergrade Healthcare Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K934133

510(k) Number K934133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date January 07, 1994
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K934133.
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
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
COMFIT BLUE POWDER FREE EXAMINATION GLOVE
K934813 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993