Cleared Traditional

K123590 - VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

K123590 is an FDA 510(k) clearance for VINYL EXAMINATION POWDER FREE GLOVES, manufactured by Weilin Plastic and Rubber 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 208-day FDA review.

K123590 · Weilin Plastic and Rubber Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
208d
Days
Class 1
Risk

K123590 is an FDA 510(k) clearance for the VINYL EXAMINATION POWDER FREE GLOVES, CLEAR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Weilin Plastic and Rubber Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on June 17, 2013 after a review of 208 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 - K123590

510(k) Number K123590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date June 17, 2013
Days to Decision 208 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
79d slower than avg
Panel avg: 129d · This submission: 208d
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 K123590.
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
POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K122396 · Wealth on (Jiangsu) Co., Ltd. · Jan 2013
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122828 · Shandong Hongxin Chemicals Co., Ltd. · Dec 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122835 · Yuanhang Plastic Co., Ltd. · Dec 2012
K123590 · VINYL EXAMINATION POWDER FREE GLOVES, CLEAR
Download PDF FDA Summary Weilin Plastic and Ru…