Cleared Traditional

K021855 - TOP GLOVE POWDERFREE LATEX EXAMINATION ...

K021855 is the FDA 510(k) clearance for TOP GLOVE POWDERFREE LATEX EXAMINATION ... by Top Glove Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K021855 · Top Glove Sdn. Bhd. · General Hospital
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Aug 2002
Decision
60d
Days
Class 1
Risk

K021855 is an FDA 510(k) clearance for the TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (5.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Top Glove Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on August 5, 2002 after a review of 60 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 Top Glove Sdn. Bhd. devices

Submission Details

510(k) Number K021855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2002
Decision Date August 05, 2002
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 207
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K021855.
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · Shen Wei (Usa), Inc. · Sep 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701 · Perusahaan Getah Asas Sdn. Bhd. · Sep 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · Allegiance Healthcare Corp. · Jul 2002
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS
K013267 · Siam Sempermed Corp., Ltd. · Mar 2002
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
K014110 · Siam Sempermed Corp., Ltd. · Feb 2002