Cleared Abbreviated

K170575 - Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

K170575 is an FDA 510(k) clearance for Disposable Powder Free Vinyl Exam Glove, manufactured by Ever Global (Vietnam) Enterprise Corp. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K170575

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 Consultant

N/A
Elizabeth Deng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 374
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
K171460 · Shandong Zhiwei Medical Products, Co. , Ltd. · Sep 2017
Clear Vinyl Powder-free Patient Examination Gloves
K171317 · Shandong Zhi Hong Medical Products, Co. , Ltd. · Sep 2017
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · Zibo Yue Fan Medical Products Co, Ltd. · Jun 2017
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
K163168 · Hebei Hongtai Plastic Products Company Limited · Feb 2017
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K162259 · Zibo Daiyang Plastic Company · Dec 2016
Vinyl Exam Gloves, Powder Free, Clear
K161390 · Zibo Hongchin Plastic and Rubber Co., Ltd. · Dec 2016