Cleared Traditional

K020040 - LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM

K020040 is an FDA 510(k) clearance for LATEX PRE-POWDERED EXAMINATION GLOVES W..., manufactured by Pt. Maja Agung Latexindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K020040 · Pt. Maja Agung Latexindo · General Hospital
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Aug 2002
Decision
206d
Days
Class 1
Risk

K020040 is an FDA 510(k) clearance for the LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Maja Agung Latexindo (Chino, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 206 days - an extended review 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: 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.

View all Pt. Maja Agung Latexindo devices

FDA 510(k) Submission Details - K020040

510(k) Number K020040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2002
Decision Date August 01, 2002
Days to Decision 206 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 129d · This submission: 206d
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 801
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K020040.
GLOVCO EBONY
K013828 · Glovco (M) Sdn. Bhd. · Aug 2002
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
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
K021950 · Top Glove Medical (Thailand) Co., Ltd. · 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