Cleared Traditional

K000872 - DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

K000872 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL SYNTHETIC ..., manufactured by Shanghai Antares Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K000872 · Shanghai Antares Industries, Inc. · General Hospital
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Apr 2000
Decision
16d
Days
Class 1
Risk

K000872 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Antares Industries, Inc. (Songjiang Shanghai, CN). The FDA issued a Cleared decision on April 5, 2000 after a review of 16 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 Shanghai Antares Industries, Inc. devices

FDA 510(k) Submission Details - K000872

510(k) Number K000872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date April 05, 2000
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

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 206
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K000872.
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · Arista Latindo Industrial Ltd. P.T · Oct 2000
VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K994098 · Evergreen Medical Produts (Jingxing) Co., Ltd. · May 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · Evergreen Medical Produts (Jingxing) Co., Ltd. · Apr 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · Shijiazhuang Great Vision Plastic Products Co., LT · Mar 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Mar 2000
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K992979 · Shanghai Poseidon Plastic Products Co., Ltd. · Feb 2000