Cleared Traditional

K010546 - POWDER FREE LATEX EXAMINATION GLOVES

K010546 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Jb Star Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K010546 · Jb Star Sdn Bhd · General Hospital
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Jul 2001
Decision
137d
Days
Class 1
Risk

K010546 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Jb Star Sdn Bhd (Littleton, US). The FDA issued a Cleared decision on July 10, 2001 after a review of 137 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K010546

510(k) Number K010546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date July 10, 2001
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010546.
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749 · Sempermed USA, Inc. · Aug 2001
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K011995 · Quality Latex Products Malaysia Sdn Bhd · Jul 2001
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
K011712 · Pt.Shamrock Manufacturing Corp. · Jul 2001
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
K011293 · Multisafe Sdn. Bhd. · Jul 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
K011728 · Brightway Holdings Sdn. Bhd. · Jul 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
K011895 · Pwa Industries Sdn. Bhd. · Jul 2001
K010546 · POWDER FREE LATEX EXAMINATION GLOVES
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