Cleared Traditional

K100059 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)

K100059 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Tangshan Zhongpu Plastic 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 174-day FDA review.

K100059 · Tangshan Zhongpu Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
174d
Days
Class 1
Risk

K100059 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Zhongpu Plastic Products Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 1, 2010 after a review of 174 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 - K100059

510(k) Number K100059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2010
Decision Date July 01, 2010
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K100059.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101840 · Shijiazhuang Sail Plastic Co., Ltd. · Jul 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K101841 · Shijiazhuang Sail Plastic Co., Ltd. · Jul 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100057 · Tangshan Kangyuan Glove Co., Ltd. · Jul 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
K101132 · Hong DI Plastic Products Co., Ltd. · Jul 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
K101135 · Hongze Plastic Technology Co., Ltd. · Jul 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K101137 · Hongze Plastic Technology Co., Ltd. · Jun 2010
K100059 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
Download PDF FDA Summary Tangshan Zhongpu Plas…