Cleared Traditional

K990285 - LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)

K990285 is an FDA 510(k) clearance for LAGLOVE BRAND LATEX EXAMINATION GLOVES ..., manufactured by La Glove (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 20-day FDA review.

K990285 · La Glove (M) Sdn. Bhd. · General Hospital
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Feb 1999
Decision
20d
Days
Class 1
Risk

K990285 is an FDA 510(k) clearance for the LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on February 18, 1999 after a review of 20 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 La Glove (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K990285

510(k) Number K990285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date February 18, 1999
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 612
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990285.
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · La Glove (M) Sdn. Bhd. · Feb 1999
GUTHRIE PRIME POWDER-FREE
K990228 · Guthrie Medicare Products (Melaka) Sdn Bhd · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · La Glove (M) Sdn. Bhd. · Feb 1999
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K984125 · Kilang Barangan Getah Dioh · Feb 1999
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K983614 · American Healthcare Products (M) Sdn Bhd · Feb 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999