Cleared Traditional

K042952 - VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE

K042952 is an FDA 510(k) clearance for VINYL EXAM GLOVE, 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.

K042952 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042952

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K042952.
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
K050450 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · Apr 2005
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
K050455 · Zibo Blue Intco Plastic & Rubber Products Co., Ltd. · Mar 2005
PRE-POWDERED VINYL EXAM GLOVES
K042951 · Zibo Hengchang Plastic & Rubber Products Co., Ltd. · Mar 2005
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K043478 · Shijaizhuang Brilliant Ocean Plastic Co., Ltd. · Mar 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K050154 · Zibo Zhuangyuan Plastic & Rubber Co., Ltd. · Feb 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K050155 · Zibo Zhuangyuan Plastic & Rubber Co., Ltd. · Feb 2005

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.

K042952 · VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
Download PDF Zibo Hengchang Plasti…