Cleared Traditional

K142571 - Powder Free Vinyl Patient Examination Gloves

K142571 is an FDA 510(k) clearance for Powder Free Vinyl Patient Examination G..., manufactured by Ever Light 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 96-day FDA review.

K142571 · Ever Light Plastic Products 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
96d
Days
Class 1
Risk

K142571 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ever Light Plastic Products Co., Ltd. (Shijiazhuang, Hebei, CN). The FDA issued a Cleared decision on December 17, 2014 after a review of 96 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 - K142571

510(k) Number K142571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date December 17, 2014
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
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

Hongray USA Medical Products, Inc.
KATHY LIU

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 739
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K142571.
Powder Free Yellow Vinyl Patient Examination Gloves
K142508 · Zibo Huaqi Trading Co., Ltd. · Dec 2014
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142342 · Nacrous Plastic Co., Ltd. · Dec 2014
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
K142570 · Ever Light Plastic Products Co., Ltd. · Dec 2014
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
K142343 · Tangshan Hongyun Plastic Products Co., Ltd. · Dec 2014
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · Grand Work Plastic Products Co., Ltd. · Dec 2014
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
K141613 · Zibo Goldenline Plastic Product Co., Ltd. · Dec 2014
K142571 · Powder Free Vinyl Patient Examination Gloves
Download PDF FDA Summary Ever Light Plastic Pr…