Cleared Traditional

K981942 - LATEX POWDER FREE EXAMINATION GLOVES

K981942 is an FDA 510(k) clearance for LATEX POWDER FREE EXAMINATION GLOVES, manufactured by Maika Rubber Products Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K981942 · Maika Rubber Products Sdn Bhd · General Hospital
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Dec 1998
Decision
195d
Days
Class 1
Risk

K981942 is an FDA 510(k) clearance for the LATEX POWDER FREE EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Maika Rubber Products Sdn Bhd (Libertyville, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 195 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 Maika Rubber Products Sdn Bhd devices

FDA 510(k) Submission Details - K981942

510(k) Number K981942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1998
Decision Date December 14, 1998
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981942.
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
K984020 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · Vitalcare Group, Inc. · Dec 1998
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
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