Cleared Traditional

VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE (K042952) - FDA 510(k) Clearance

Class I General Hospital device.

K042952 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · General Hospital
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Mar 2005
Decision
135d
Days
Class 1
Risk

K042952 is an FDA 510(k) clearance for the VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE. 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

Submission Details

510(k) Number K042952 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.

Device Classification

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 84
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K042952.
Vinyl Patient Examination Glove (Yellow)
K173580 · Nature Medical Products Co., Ltd. · Feb 2018
Vinyl Patient Examination Glove (Yellow)
K173561 · Yurun Glove Co., Ltd. · Feb 2018
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · Medline Industries, Inc. · Aug 1996
TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES
K952786 · Baxter Healthcare Corp · Jul 1995