Cleared Traditional

K913279 - LATEX EXAMINATION GLOVES

K913279 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES, manufactured by Liwe Trading. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K913279 · Liwe Trading · General Hospital
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Sep 1991
Decision
62d
Days
Class 1
Risk

K913279 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Liwe Trading (Selangor, Malaysia, MY). The FDA issued a Cleared decision on September 23, 1991 after a review of 62 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 Liwe Trading devices

FDA 510(k) Submission Details - K913279

510(k) Number K913279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1991
Decision Date September 23, 1991
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 585
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K913279.
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K913409 · Top Glove Sdn. Bhd. · Sep 1991
LATEX EXAMINATION GLOVES
K912988 · La Glove (M) Sdn. Bhd. · Aug 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · Aladan Corp. · Apr 1991