Cleared Traditional

K994082 - POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)

K994082 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES (PROT..., manufactured by Besglove Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K994082 · Besglove Medicare Sdn. Bhd. · General Hospital
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Jan 2000
Decision
56d
Days
Class 1
Risk

K994082 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Besglove Medicare Sdn. Bhd. (Kajang,Selangor Darul,Ehasan, MY). The FDA issued a Cleared decision on January 28, 2000 after a review of 56 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 Besglove Medicare Sdn. Bhd. devices

FDA 510(k) Submission Details - K994082

510(k) Number K994082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date January 28, 2000
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 810
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994082.
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · Pt. Maja Agung Latexindo · Feb 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416 · Flexitech Sdn. Bhd. · Feb 2000
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994354 · Flexitech Sdn. Bhd. · Jan 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · Supermax Sdn Bhd · Jan 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · Supermax Sdn Bhd · Jan 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K994013 · Glovco (M) Sdn. Bhd. · Jan 2000