Cleared Traditional

K131832 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

K131832 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shandong Binxiang 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 201-day FDA review.

K131832 · Shandong Binxiang Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
201d
Days
Class 1
Risk

K131832 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Binxiang Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on January 7, 2014 after a review of 201 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 - K131832

510(k) Number K131832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date January 07, 2014
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
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 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K131832.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K132221 · Shandong Haoyu Medical Products Co., Ltd. · Jan 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131344 · Shijiazhuang Wally Plastics Co., Ltd. · Jan 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130732 · Aide Plastic Co., Ltd. · Jan 2014
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
K132201 · Zibo Intco Medical Products Co., Ltd. · Nov 2013
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
K131828 · Jiangsu Handsafe Glove Co., Ltd. · Nov 2013
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
K131826 · Jiangsu Toptouch Glove Co., Ltd. · Nov 2013
K131832 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Shandong Binxiang Med…