Cleared Traditional

K160675 - Powder free vinyl patient examination glove, colored (yellow)

K160675 is an FDA 510(k) clearance for Powder free vinyl patient examination glove, manufactured by Kaixing Plastic Products Co., Litd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K160675 · Kaixing Plastic Products Co., Litd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
145d
Days
Class 1
Risk

K160675 is an FDA 510(k) clearance for the Powder free vinyl patient examination glove, colored (yellow). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Kaixing Plastic Products Co., Litd. (Tangshan, CN). The FDA issued a Cleared decision on August 2, 2016 after a review of 145 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.

FDA 510(k) Submission Details - K160675

510(k) Number K160675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2016
Decision Date August 02, 2016
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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

Lichen Commercial Information Consulting Co.,Ltd
Daniel Qiu

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 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K160675.
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
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · Cardinal Health, Inc. · Jul 2016
Powder Free Grey Vinyl Examination Gloves
K161072 · Zibo Flourish Trading Co., Ltd. · Jul 2016
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
K160468 · Inpro Technology Device Factory · Jun 2016