Cleared Traditional

K981979 - UNISEAL GLOVES LOW PROTEIN POWDERED

K981979 is an FDA 510(k) clearance for UNISEAL GLOVES LOW PROTEIN POWDERED, manufactured by American Healthcare 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 178-day FDA review.

K981979 · American Healthcare Products (M) Sdn Bhd · General Hospital
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Nov 1998
Decision
178d
Days
Class 1
Risk

K981979 is an FDA 510(k) clearance for the UNISEAL GLOVES LOW PROTEIN POWDERED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by American Healthcare Products (M) Sdn Bhd (Nilai, Negeri Sembilan 71800, MY). The FDA issued a Cleared decision on November 30, 1998 after a review of 178 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 American Healthcare Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K981979

510(k) Number K981979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1998
Decision Date November 30, 1998
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
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 817
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981979.
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K981917 · Oon Corp. Resources · Dec 1998
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
K983721 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · Ansell Perry · Nov 1998
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
K982716 · Omnigrace (Thailand) , Ltd. · Nov 1998
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
K982877 · Matang Mfg. Sdn. Bhd. · Nov 1998