Cleared Special

K020943 - STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE

K020943 is an FDA 510(k) clearance for STERILE DISPOSABLE VINYL EXAM GLOVES, manufactured by Shanghai Antares Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Special 510(k) pathway after a 73-day FDA review.

K020943 · Shanghai Antares Industries, Inc. · General Hospital
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Jun 2002
Decision
73d
Days
Class 1
Risk

K020943 is an FDA 510(k) clearance for the STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Antares Industries, Inc. (Songjiang County, Shanghai, CN). The FDA issued a Cleared decision on June 6, 2002 after a review of 73 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020943

510(k) Number K020943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date June 06, 2002
Days to Decision 73 days
Submission Type Special
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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K020943.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K022087 · Shanghai PT Plastics Enterprise Company, Ltd. · Jul 2002
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K021961 · Copioumed Intl., Inc. · Jul 2002
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K021667 · Safehealth Medical Supply Corp. · Jun 2002
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
K021353 · Glormed Intl., Inc. · Jun 2002
VINYL EXAMINATION GLOVES STERILE POWEDERED
K020044 · Primus Gloves Private , Ltd. · Feb 2002
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K013753 · Canopus Medical Supply Co., Ltd. · Dec 2001
K020943 · STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
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