Cleared Traditional

K964724 - POWDER-FREE LATEX EXAMINATION GLOVES

K964724 is an FDA 510(k) clearance for POWDER-FREE LATEX EXAMINATION GLOVES, manufactured by Pwa Industries Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K964724 · Pwa Industries Sdn. Bhd. · General Hospital
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Jun 1997
Decision
213d
Days
Class 1
Risk

K964724 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 Pwa Industries Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on June 16, 1997 after a review of 213 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 Pwa Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K964724

510(k) Number K964724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date June 16, 1997
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
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 K964724.
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · Ansell Perry · Sep 1997
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)
K971629 · Besglove Medicare Sdn. Bhd. · Aug 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · Allegiance Healthcare Corp. · Jul 1997
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K971424 · Ansell Perry · Jun 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · Safeskin Corp. · May 1997