Cleared Traditional

K042951 - PRE-POWDERED VINYL EXAM GLOVES

K042951 is an FDA 510(k) clearance for PRE-POWDERED VINYL EXAM GLOVES, manufactured by Zibo Hengchang Plastic & Rubber 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 135-day FDA review.

K042951 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · General Hospital
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Mar 2005
Decision
135d
Days
Class 1
Risk

K042951 is an FDA 510(k) clearance for the PRE-POWDERED VINYL EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Hengchang Plastic & Rubber Products Co., Ltd. (Rancho Mirage, US). The FDA issued a Cleared decision on March 10, 2005 after a review of 135 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zibo Hengchang Plastic & Rubber Products Co., Ltd. devices

FDA 510(k) Submission Details - K042951

510(k) Number K042951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2004
Decision Date March 10, 2005
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. 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 277
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K042951.
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K042830 · Grand Work Plastic Products Co., Ltd. · Nov 2004
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