Cleared Traditional

K932332 - PATIENT EXAMINATION GLOVE - POWDERED

K932332 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVE - POWDERED, manufactured by Sj Medical 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 306-day FDA review.

K932332 · Sj Medical Products (M) Sdn Bhd · General Hospital
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Mar 1994
Decision
306d
Days
Class 1
Risk

K932332 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE - POWDERED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sj Medical Products (M) Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on March 15, 1994 after a review of 306 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sj Medical Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K932332

510(k) Number K932332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date March 15, 1994
Days to Decision 306 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
177d slower than avg
Panel avg: 129d · This submission: 306d
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 440
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K932332.
POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K935864 · Wembley Rubber Products (M) Sdn Bhd · May 1994
SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE
K940873 · Aladan Corp. · Apr 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
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