Cleared Traditional

K142771 - Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K142771 is an FDA 510(k) clearance for Xuanye Powder Free Vinyl Patient Examin..., manufactured by Xuanhua Metallurgical Industry Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K142771 · Xuanhua Metallurgical Industry Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
88d
Days
Class 1
Risk

K142771 is an FDA 510(k) clearance for the Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xuanhua Metallurgical Industry Co., Ltd. (Zhangjiakou, CN). The FDA issued a Cleared decision on December 22, 2014 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K142771

510(k) Number K142771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date December 22, 2014
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 K142771.
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K141878 · Tangshan Hongyun Plastic Products Co., Ltd. · Dec 2014
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Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
K142570 · Ever Light Plastic Products Co., Ltd. · Dec 2014
K142771 · Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Download PDF FDA Summary Xuanhua Metallurgical…