Cleared Traditional

K131828 - POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR

K131828 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Jiangsu Handsafe 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 159-day FDA review.

K131828 · Jiangsu Handsafe 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
159d
Days
Class 1
Risk

K131828 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Handsafe Glove Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 26, 2013 after a review of 159 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 - K131828

510(k) Number K131828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date November 26, 2013
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
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 K131828.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
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K132201 · Zibo Intco Medical Products Co., Ltd. · Nov 2013
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K131826 · Jiangsu Toptouch Glove Co., Ltd. · Nov 2013
BYTECH
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POWER FREE VINYL EXAMINATION GLOVES
K122102 · Wang Tong Xinghua Co., Ltd. · Sep 2013
K131828 · POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
Download PDF FDA Summary Jiangsu Handsafe Glov…