Cleared Abbreviated

K172357 - Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

K172357 is an FDA 510(k) clearance for Disposable Powder Free Vinyl Exam Glove, manufactured by Ever Growth (Vietnam) Co. , Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Abbreviated 510(k) pathway after a 148-day FDA review.

K172357 · Ever Growth (Vietnam) Co. , Ltd. · General Hospital
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Dec 2017
Decision
148d
Days
Class 1
Risk

K172357 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 Growth (Vietnam) Co. , Ltd. (Long Khanh Township, VN). The FDA issued a Cleared decision on December 29, 2017 after a review of 148 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 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 Growth (Vietnam) Co. , Ltd. devices

FDA 510(k) Submission Details - K172357

510(k) Number K172357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2017
Decision Date December 29, 2017
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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

Pm Gloves, Inc.
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 638
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K172357.
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
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K173017 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · Dec 2017
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
K173016 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · Nov 2017
STERILE VINYL EXAMINATION GLOVES, Powder Free
K170612 · Primus Gloves Pvt Limited · Oct 2017