Cleared Traditional

K131826 - TOPTOUCH /OTHER CLIENTS PRIVATE LABELING

K131826 is an FDA 510(k) clearance for TOPTOUCH /OTHER CLIENTS PRIVATE LABELING, manufactured by Jiangsu Toptouch Glove Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K131826 · Jiangsu Toptouch Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
155d
Days
Class 1
Risk

K131826 is an FDA 510(k) clearance for the TOPTOUCH /OTHER CLIENTS PRIVATE LABELING. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Toptouch Glove Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 22, 2013 after a review of 155 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 - K131826

510(k) Number K131826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date November 22, 2013
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 K131826.
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K131832 · Shandong Binxiang Medical Products 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
BYTECH
K130101 · Bytech Dongtai Co., Ltd. · Nov 2013
POWER FREE VINYL EXAMINATION GLOVES
K122102 · Wang Tong Xinghua Co., Ltd. · Sep 2013
POWDERED VINYL EXAMINATION GLOVES
K122100 · Wang Tong Xinghua Co., Ltd. · Aug 2013
K131826 · TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
Download PDF FDA Summary Jiangsu Toptouch Glov…