Cleared Traditional

K983721 - POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE

K983721 is an FDA 510(k) clearance for POLYMER-COATED, manufactured by Kossan Latex Industries(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 46-day FDA review.

K983721 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
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Dec 1998
Decision
46d
Days
Class 1
Risk

K983721 is an FDA 510(k) clearance for the POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on December 7, 1998 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kossan Latex Industries(M)Sdn Bhd devices

FDA 510(k) Submission Details - K983721

510(k) Number K983721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date December 07, 1998
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 630
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983721.
OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K983568 · Contract Latex Dippers Sdn Bhd · Dec 1998
LATEX POWDER FREE EXAMINATION GLOVES
K981942 · Maika Rubber Products Sdn Bhd · Dec 1998
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K981917 · Oon Corp. Resources · Dec 1998
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · American Healthcare Products (M) Sdn Bhd · Nov 1998
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · Ansell Perry · Nov 1998