Cleared Traditional

K020363 - GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)

K020363 is an FDA 510(k) clearance for GREAT GLOVE LATEX EXAMINATION POWDERFRE..., manufactured by Great Glove Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K020363 · Great Glove Sdn Bhd · General Hospital
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Apr 2002
Decision
65d
Days
Class 1
Risk

K020363 is an FDA 510(k) clearance for the GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Great Glove Sdn Bhd (Kapar, Selangor D.E., MY). The FDA issued a Cleared decision on April 10, 2002 after a review of 65 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.

FDA 510(k) Submission Details - K020363

510(k) Number K020363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date April 10, 2002
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K020363.
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
K020865 · Apl Products Sdn. Bhd. · May 2002
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
K020053 · Safe Shield Co., Ltd. · May 2002
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K020838 · Ar Alliance Healthcare Sdn. Bhd. · Apr 2002
LATEX EXAMINATION GLOVES (POWDER FREE)
K014279 · Brightway Gloves Pvt. , Ltd. · Mar 2002
LATEX EXAMINATION GLOVE (POWDERED)
K014280 · Brightway Gloves Pvt. , Ltd. · Mar 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
K020363 · GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
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