Cleared Abbreviated

K041041 - NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

K041041 is an FDA 510(k) clearance for NON STERILE SYNTHETIC POWDER FREE (YELL..., 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 47-day FDA review.

K041041 · Shanghai Foremost Plastic Industrial Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
47d
Days
Class 1
Risk

K041041 is an FDA 510(k) clearance for the NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Foremost Plastic Industrial Co., Ltd. (Clearwater, US). The FDA issued a Cleared decision on June 8, 2004 after a review of 47 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 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 - K041041

510(k) Number K041041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date June 08, 2004
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 K041041.
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040682 · Grand Work Plastic Products Co., Ltd. · Jul 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED
K041225 · Grand Work Plastic Products Co., Ltd. · Jul 2004
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
K041745 · Arista Latindo Industrial Ltd. P.T · Jul 2004
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040681 · Grand Work Plastic Products Co., Ltd. · Jun 2004
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED
K041188 · Grand Work Plastic Products Co., Ltd. · Jun 2004
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K040702 · Grand Work Plastic Products Co., Ltd. · Apr 2004