Cleared Traditional

K991749 - LAGLOVE BRAND BLUE COLOR LATEX EXAMINAT...

K991749 is the FDA 510(k) clearance for LAGLOVE BRAND BLUE COLOR LATEX EXAMINAT... by La Glove (M) Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K991749 · La Glove (M) Sdn. Bhd. · General Hospital
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Jun 1999
Decision
30d
Days
Class 1
Risk

K991749 is an FDA 510(k) clearance for the LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 M.... 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 June 23, 1999 after a review of 30 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

Submission Details

510(k) Number K991749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date June 23, 1999
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 130
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991749.
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
K993725 · Hartalega Sdn Bhd · Nov 1999
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
K992200 · Shen Wei (Usa), Inc. · Aug 1999
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991616 · Hartalega Sdn Bhd · Jul 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145 · Shen Wei (Usa), Inc. · Jan 1999