Cleared Traditional

K173017 - Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K173017 is an FDA 510(k) clearance for Kindguard Powder Free Vinyl Patient Exa..., manufactured by Anhui Kindguard Medical Supplies Technology Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K173017 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · General Hospital
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Dec 2017
Decision
79d
Days
Class 1
Risk

K173017 is an FDA 510(k) clearance for the Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Anhui Kindguard Medical Supplies Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 15, 2017 after a review of 79 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Anhui Kindguard Medical Supplies Technology Co., Ltd. devices

FDA 510(k) Submission Details - K173017

510(k) Number K173017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date December 15, 2017
Days to Decision 79 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

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

Beijing Easylink Co., Ltd.
Chu Xiaoan

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 640
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K173017.
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
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K172357 · Ever Growth (Vietnam) 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
Powder-free Clear Vinyl Patient Examination Gloves
K171460 · Shandong Zhiwei Medical Products, Co. , Ltd. · Sep 2017