Cleared Traditional

K152719 - Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves

K152719 is an FDA 510(k) clearance for Xinfu Powder-Free Yellow Vinyl Patient ..., manufactured by Xinfu Medical 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 162-day FDA review.

K152719 · Xinfu Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
162d
Days
Class 1
Risk

K152719 is an FDA 510(k) clearance for the Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xinfu Medical Products Co., Ltd. (Tangshan City, CN). The FDA issued a Cleared decision on March 1, 2016 after a review of 162 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 - K152719

510(k) Number K152719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date March 01, 2016
Days to Decision 162 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 slower than avg
Panel avg: 129d · This submission: 162d
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 K152719.
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
K160468 · Inpro Technology Device Factory · Jun 2016
Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves
K152818 · Ideal Plastic Co., Ltd. · May 2016
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
K153028 · Zibo Huiying Medical Products, Co. , Ltd. · Feb 2016
Vinyl patient examination glove, Powder Free
K153159 · Xingyuan Plastic Products Co., Ltd. · Jan 2016
Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
K150934 · Lpl (Hui Zhou) Glove · Dec 2015