Cleared Traditional

K163168 - Vinyl Examination Gloves (White)

K163168 is an FDA 510(k) clearance for Vinyl Examination Gloves (White), manufactured by Hebei Hongtai Plastic Products Company Limited. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K163168 · Hebei Hongtai Plastic Products Company Limited · General Hospital
Download Printable Device Report (PDF)
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Feb 2017
Decision
101d
Days
Class 1
Risk

K163168 is an FDA 510(k) clearance for the Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Exam.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Hebei Hongtai Plastic Products Company Limited (Xingtai, CN). The FDA issued a Cleared decision on February 23, 2017 after a review of 101 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Hebei Hongtai Plastic Products Company Limited devices

FDA 510(k) Submission Details - K163168

510(k) Number K163168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date February 23, 2017
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 121
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K163168.
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
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · Grand Work Plastic Products Co., Ltd. · Dec 2014