Cleared Traditional

K153159 - Vinyl patient examination glove, Powder Free

K153159 is an FDA 510(k) clearance for Vinyl patient examination glove, manufactured by Xingyuan 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 85-day FDA review.

K153159 · Xingyuan 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 2016
Decision
85d
Days
Class 1
Risk

K153159 is an FDA 510(k) clearance for the Vinyl patient examination glove, Powder Free. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xingyuan Plastic Products Co., Ltd. (Tangshan, CN). The FDA issued a Cleared decision on January 26, 2016 after a review of 85 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 - K153159

510(k) Number K153159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2015
Decision Date January 26, 2016
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 Believe Tech.Service Co., Ltd.
RAY WANG

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 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K153159.
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves
K152719 · Xinfu Medical Products Co., Ltd. · Mar 2016
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
K153028 · Zibo Huiying Medical Products, Co. , Ltd. · Feb 2016
Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
K150934 · Lpl (Hui Zhou) Glove · Dec 2015
Powder Free Vinyl Patient Examination Gloves (Green)
K152692 · Supermax Plastic Products Co., Ltd. · Dec 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151679 · Heze Yuze Glove Co., Ltd. · Nov 2015