Cleared Traditional

K100057 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

K100057 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Tangshan Kangyuan 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 181-day FDA review.

K100057 · Tangshan Kangyuan Glove 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
181d
Days
Class 1
Risk

K100057 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Kangyuan Glove Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 8, 2010 after a review of 181 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 - K100057

510(k) Number K100057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2010
Decision Date July 08, 2010
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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 K100057.
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101343 · Shijiazhuang Star Plastic Co., Ltd. · Jul 2010
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 (WHITE)
K100059 · Tangshan Zhongpu Plastic Products 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
K100057 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Download PDF FDA Summary Tangshan Kangyuan Glo…