Cleared Traditional

K142911 - ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K142911 is an FDA 510(k) clearance for ZM Powder Free Vinyl Patient Examinatio..., manufactured by Huailai ZM 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 186-day FDA review.

K142911 · Huailai ZM Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
186d
Days
Class 1
Risk

K142911 is an FDA 510(k) clearance for the ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Huailai ZM Plastic Products Co., Ltd. (Zhangjiakou, CN). The FDA issued a Cleared decision on April 10, 2015 after a review of 186 days - an extended review 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: 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 - K142911

510(k) Number K142911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2014
Decision Date April 10, 2015
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
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 Consultant

Beijing Easylink Co., Ltd.
CHU XIAOAN

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 738
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K142911.
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K150224 · Zibo Sanying Trade Co., Ltd. · May 2015
Powder-free Clear Vinyl Patient Examination Gloves
K142892 · Shenyi (Shandong) Plastic Products Co., Ltd. · Mar 2015
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K141224 · Shijiazhunag Jiuyuan Plastic Co., Ltd. · Jan 2015
Powder-free PVC Vinyl Exam Gloves
K142703 · Hebei Grandeast Plastic Products Co., Ltd. · Jan 2015
K142911 · ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Download PDF FDA Summary Huailai ZM Plastic Pr…