Cleared Traditional

K173016 - Kindguard Powder Free Vinyl Patient Exa...

K173016 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 49-day FDA review.

K173016 · Anhui Kindguard Medical Supplies Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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Nov 2017
Decision
49d
Days
Class 1
Risk

K173016 is an FDA 510(k) clearance for the Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color. 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 November 15, 2017 after a review of 49 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 - K173016

510(k) Number K173016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date November 15, 2017
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
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 Peers - LYZ Vinyl Patient Examination Glove

All 100
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K173016.
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
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · Cardinal Health, Inc. · Jul 2016
Glide-On Vinyl Examination Gloves
K151754 · Medline Industries, Inc. · Mar 2016
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005