Cleared Abbreviated

K112741 - POWDER FREE VINYL PATIENT EXAMINATION GLOVE

K112741 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION GLOVE, manufactured by Lifestyle Safty Products (Hui Zhou) Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 358-day FDA review.

K112741 · Lifestyle Safty Products (Hui Zhou) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
358d
Days
Class 1
Risk

K112741 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Lifestyle Safty Products (Hui Zhou) Co., Ltd. (Hampton, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Lifestyle Safty Products (Hui Zhou) Co., Ltd. devices

FDA 510(k) Submission Details - K112741

510(k) Number K112741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2011
Decision Date September 13, 2012
Days to Decision 358 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 129d · This submission: 358d
Pathway characteristics
Standards-based clearance path.

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 123
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K112741.
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
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR
K061562 · Grand Work Plastic Products Co., Ltd. · Jul 2006