Cleared Abbreviated

K032071 - POWDER FREE VINYL EXAMINATION GLOVE

K032071 is an FDA 510(k) clearance for POWDER FREE VINYL EXAMINATION GLOVE, manufactured by Shanghai Foremost Plastic Industrial Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K032071 · Shanghai Foremost Plastic Industrial Co., Ltd. · General Hospital
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Oct 2003
Decision
99d
Days
Class 1
Risk

K032071 is an FDA 510(k) clearance for the POWDER FREE VINYL EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Foremost Plastic Industrial Co., Ltd. (Palm Harbor, US). The FDA issued a Cleared decision on October 10, 2003 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shanghai Foremost Plastic Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K032071

510(k) Number K032071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2003
Decision Date October 10, 2003
Days to Decision 99 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 140
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K032071.
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · Shen Wei (Usa), Inc. · Jan 2004
POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR
K032084 · Shen Wei (Usa), Inc. · Oct 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · Kimberly-Clark Corp. · Oct 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · Arista Latindo Industrial Ltd. P.T · Jul 2003
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
K023753 · Arista Latindo Industrial Ltd. P.T · Mar 2003
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
K023754 · Arista Latindo Industrial Ltd. P.T · Mar 2003