Cleared Abbreviated

K170575 - Disposable Powder Free Vinyl Exam Glove

K170575 is the FDA 510(k) clearance for Disposable Powder Free Vinyl Exam Glove by Ever Global (Vietnam) Enterprise Corp. It is a Class 1 General Hospital device (product code LYZ) cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K170575 · Ever Global (Vietnam) Enterprise Corp · General Hospital
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May 2017
Decision
78d
Days
Class 1
Risk

K170575 is an FDA 510(k) clearance for the Disposable Powder Free Vinyl Exam Glove, Clear/Yellow. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ever Global (Vietnam) Enterprise Corp (Dong Nai Province, VN). The FDA issued a Cleared decision on May 16, 2017 after a review of 78 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 Ever Global (Vietnam) Enterprise Corp devices

Submission Details

510(k) Number K170575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2017
Decision Date May 16, 2017
Days to Decision 78 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 91
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K170575.
Powder-free Clear Vinyl Patient Examination Gloves
K173078 · Yongsheng Medical Products Co., Ltd. · Mar 2018
Vinyl Patient Examination Glove (Yellow)
K173580 · Nature Medical Products Co., Ltd. · Feb 2018
Vinyl Patient Examination Glove (Yellow)
K173561 · Yurun Glove Co., Ltd. · Feb 2018
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · Shen Wei (Usa), Inc. · Aug 2005
POWDERED VINYL EXAMINATION GLOVES
K033692 · Shen Wei (Usa), Inc. · Jan 2004