Cleared Traditional

K150934 - Powder Free Vinyl Patient Examination Glove (Non?-Sterile)

K150934 is an FDA 510(k) clearance for Powder Free Vinyl Patient Examination G..., manufactured by Lpl (Hui Zhou) Glove. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K150934 · Lpl (Hui Zhou) Glove · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
259d
Days
Class 1
Risk

K150934 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Glove (Non?-Sterile). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Lpl (Hui Zhou) Glove (Huizhou City, CN). The FDA issued a Cleared decision on December 21, 2015 after a review of 259 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 - K150934

510(k) Number K150934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date December 21, 2015
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
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 K150934.
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
Vinyl patient examination glove, Powder Free
K153159 · Xingyuan Plastic Products Co., Ltd. · Jan 2016
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
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151682 · Daxwell, LLC · Nov 2015