Cleared Traditional

K040681 - SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE

K040681 is an FDA 510(k) clearance for SYNTHETIC (WHITE) VINYL PATIENT EXAMINA..., manufactured by Grand Work Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K040681 · Grand Work Plastic Products Co., Ltd. · General Hospital
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Jun 2004
Decision
79d
Days
Class 1
Risk

K040681 is an FDA 510(k) clearance for the SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Grand Work Plastic Products Co., Ltd. (Zanhuang County, CN). The FDA issued a Cleared decision on June 3, 2004 after a review of 79 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 Grand Work Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K040681

510(k) Number K040681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date June 03, 2004
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
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 644
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K040681.
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
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
K041325 · Est International Corporation · Jul 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
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004