Cleared Traditional

K143347 - Powder-Free Yellow Vinyl Patient Examination Gloves

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K143347.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151679 · Heze Yuze Glove Co., Ltd. · Nov 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151682 · Daxwell, LLC · Nov 2015
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
K143277 · Lifestyle Safety Products (Hui Zhou) Co., Ltd. · Jul 2015
Powder-Free White Vinyl Patient Examination Gloves
K143346 · Zibo Changda Plastic Products Company, Limited · Jul 2015
Powder Free Vinyl Patient Examination Gloves, Yellow Color
K143340 · Zibo Ling Yun Medical Products Co, Ltd. · Jul 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K143715 · Better Plastic Co., Ltd. · Jun 2015