Cleared Abbreviated

POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE (K111598) - FDA 510(k) Clearance

Class I General Hospital device.

K111598 · Lpl (Hui Zhou) Glove Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
42d
Days
Class 1
Risk

K111598 is an FDA 510(k) clearance for the POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Lpl (Hui Zhou) Glove Co., Ltd. (Hampton, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 42 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 Lpl (Hui Zhou) Glove Co., Ltd. devices

Submission Details

510(k) Number K111598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date July 20, 2011
Days to Decision 42 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K111598.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
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Powder-Free Vinyl Exam Gloves, clear
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K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
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K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Mar 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980 · Ever Global (Vietnam) Enterprise Corporation · Feb 2023