Cleared Traditional

K142703 - Powder-free PVC Vinyl Exam Gloves

K142703 is an FDA 510(k) clearance for Powder-free PVC Vinyl Exam Gloves, manufactured by Hebei Grandeast 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 115-day FDA review.

K142703 · Hebei Grandeast Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
115d
Days
Class 1
Risk

K142703 is an FDA 510(k) clearance for the Powder-free PVC Vinyl Exam Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hebei Grandeast Plastic Products Co., Ltd. (Xingtai, CN). The FDA issued a Cleared decision on January 15, 2015 after a review of 115 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 - K142703

510(k) Number K142703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date January 15, 2015
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 K142703.
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142911 · Huailai ZM Plastic Products Co., Ltd. · Apr 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
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141878 · Tangshan Hongyun Plastic Products Co., Ltd. · Dec 2014
Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142771 · Xuanhua Metallurgical Industry Co., Ltd. · Dec 2014
Powder Free Yellow Vinyl Patient Examination Gloves
K142508 · Zibo Huaqi Trading Co., Ltd. · Dec 2014
K142703 · Powder-free PVC Vinyl Exam Gloves
Download PDF FDA Summary Hebei Grandeast Plast…