Cleared Traditional

K110857 - POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR

K110857 is an FDA 510(k) clearance for POWDER-FREE VINYL PATIENT EXAMINATION G..., manufactured by Shandong Zhanpeng Medical 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 109-day FDA review.

K110857 · Shandong Zhanpeng Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
109d
Days
Class 1
Risk

K110857 is an FDA 510(k) clearance for the POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Zhanpeng Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on July 15, 2011 after a review of 109 days - within the typical 510(k) review window.

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 - K110857

510(k) Number K110857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2011
Decision Date July 15, 2011
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 K110857.
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
K110966 · Ppp Medical and Safety Products Company Limited · Jul 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110970 · Ppp Medical and Safety Products Company Limited · Jul 2011
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE
K111598 · Lpl (Hui Zhou) Glove Co., Ltd. · Jul 2011
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
K111240 · Xuzhou Full Sun Medical Products , Ltd. · Jul 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
K111012 · True Glove Factory · Jul 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K111297 · Premier Medical Gloves Factory · Jun 2011
K110857 · POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Download PDF FDA Summary Shandong Zhanpeng Med…