Cleared Abbreviated

K111240 - DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR

K111240 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL SYNTHETIC ..., manufactured by Xuzhou Full Sun Medical Products , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

K111240 · Xuzhou Full Sun Medical Products , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
72d
Days
Class 1
Risk

K111240 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Xuzhou Full Sun Medical Products , Ltd. (Rancho Cuamonga, US). The FDA issued a Cleared decision on July 14, 2011 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Xuzhou Full Sun Medical Products , Ltd. devices

FDA 510(k) Submission Details - K111240

510(k) Number K111240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2011
Decision Date July 14, 2011
Days to Decision 72 days
Submission Type Abbreviated
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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Standards-based clearance path.

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 660
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K111240.
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
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K110857 · Shandong Zhanpeng Medical Products Co., 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
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K111459 · Jiangsu Alfa Glove Co., Ltd. · Jun 2011