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.

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
Combination Product No
PCCP Authorized No
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 1324
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K932332.
BIOSHIELD BLUE LATEX GLOVES
K940256 · Chester Labs, Inc. · Mar 1994
RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED
K933759 · Perusahaan Pelindung Getah (M) Sdn Bhd · Mar 1994
PATIENT EXAMINATION GLOVES (POWDER FREE)
K932116 · Evergrade Healthcare Products Sdn Bhd · Mar 1994
SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES
K933224 · Slim River Latex Sdn. Bhd. · Mar 1994
GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES
K934316 · Contract Latex Dippers Sdn Bhd · Mar 1994
SHIELDTEX STERILE PATIENT EXAMINATION GLOVES
K940387 · Shieldtex Sdn Bhd · Mar 1994
K932332 · PATIENT EXAMINATION GLOVE - POWDERED
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