Cleared Traditional

K143347 - Powder-Free Yellow Vinyl Patient Examin...

K143347 is an FDA 510(k) clearance for Powder-Free Yellow Vinyl Patient Examin..., manufactured by Zibo Zhouheng 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 245-day FDA review.

K143347 · Zibo Zhouheng Plastic Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2015
Decision
245d
Days
Class 1
Risk

K143347 is an FDA 510(k) clearance for the Powder-Free Yellow Vinyl Patient Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Zhouheng Plastic Products Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on July 24, 2015 after a review of 245 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.

View all Zibo Zhouheng Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K143347

510(k) Number K143347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2014
Decision Date July 24, 2015
Days to Decision 245 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 129d · This submission: 245d
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 Peers - LYZ Vinyl Patient Examination Glove

All 121
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K143347.
Vinyl Patient Examination Glove (Yellow)
K173561 · Yurun Glove Co., Ltd. · Feb 2018
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · Cardinal Health, Inc. · Jul 2016
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · Grand Work Plastic Products Co., Ltd. · Dec 2014
GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102089 · Grand Work Plastic Products Co., Ltd. · Oct 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102094 · Grand Work Plastic Products Co., Ltd. · Oct 2010