Cleared Traditional

K021950 - TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES

K021950 is an FDA 510(k) clearance for TOP GLOVE MEDICAL (THAILAND) POWDERED L..., manufactured by Top Glove Medical (Thailand) Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K021950 · Top Glove Medical (Thailand) Co., Ltd. · General Hospital
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Aug 2002
Decision
49d
Days
Class 1
Risk

K021950 is an FDA 510(k) clearance for the TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Top Glove Medical (Thailand) Co., Ltd. (Songkhla, TH). The FDA issued a Cleared decision on August 1, 2002 after a review of 49 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 Medical (Thailand) Co., Ltd. devices

FDA 510(k) Submission Details - K021950

510(k) Number K021950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date August 01, 2002
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 817
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K021950.
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
K021659 · P.T. Healthcare Glovindo · Aug 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
K021855 · Top Glove Sdn. Bhd. · Aug 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
K020040 · Pt. Maja Agung Latexindo · Aug 2002
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
K020042 · Hycare Intl. Co., Ltd. · Jul 2002
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
K021041 · W.A. Rubbermate Co., Ltd. · Jul 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · Allegiance Healthcare Corp. · Jul 2002