Cleared Traditional

K162259 - DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K162259 is an FDA 510(k) clearance for DAIYANG Powder Free Vinyl Patient Exami..., manufactured by Zibo Daiyang Plastic Company. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K162259 · Zibo Daiyang Plastic Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
132d
Days
Class 1
Risk

K162259 is an FDA 510(k) clearance for the DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Daiyang Plastic Company (Zibo, CN). The FDA issued a Cleared decision on December 21, 2016 after a review of 132 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 - K162259

510(k) Number K162259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2016
Decision Date December 21, 2016
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 716
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K162259.
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · Zibo Yue Fan Medical Products Co, Ltd. · Jun 2017
Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
K170575 · Ever Global (Vietnam) Enterprise Corp · May 2017
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
K163168 · Hebei Hongtai Plastic Products Company Limited · Feb 2017
Vinyl Exam Gloves, Powder Free, Clear
K161390 · Zibo Hongchin Plastic and Rubber Co., Ltd. · Dec 2016
Powder free vinyl patient examination glove, colored (yellow)
K160675 · Kaixing Plastic Products Co., Litd. · Aug 2016
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · Cardinal Health, Inc. · Jul 2016