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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Entela, Inc.
N. E. DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K032071.
SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES
K032745 · Shanghai Giantmax Plastic Product Corp. · Oct 2003
SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES
K032746 · Shanghai Giantmax Plastic Product Corp. · Oct 2003
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
K032792 · Shanghai Jiawang Industrial Co. , Ltd. · Oct 2003
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K032323 · Long First (Xiamen) Plastics Co., Ltd. · Oct 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032668 · Kingswell International, Inc. · Oct 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032630 · Kingswell International, Inc. · Oct 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K032071 · POWDER FREE VINYL EXAMINATION GLOVE
Download PDF FDA Summary Shanghai Foremost Pla…