Cleared Traditional

K030583 - POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE (FDA 510(k) Clearance)

Class I General Hospital device.

K030583 · Shen Wei (Usa), Inc. · General Hospital

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Nov 2003

Decision

259d

Days

Class 1

Risk

K030583 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 5.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on November 10, 2003 after a review of 259 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 Shen Wei (Usa), Inc. devices

Submission Details

510(k) Number	K030583 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 24, 2003
Decision Date	November 10, 2003
Days to Decision	259 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

131d slower than avg

Panel avg: 128d · This submission: 259d

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.