Cleared Traditional

K141613 - GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES

K141613 is an FDA 510(k) clearance for GOLDENLINE POWDER-FREE WHITE VINYL PATI..., manufactured by Zibo Goldenline Plastic Product Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K141613 · Zibo Goldenline Plastic Product Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
171d
Days
Class 1
Risk

K141613 is an FDA 510(k) clearance for the GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Goldenline Plastic Product Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 4, 2014 after a review of 171 days - an extended review 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: 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 - K141613

510(k) Number K141613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date December 04, 2014
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
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 741
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K141613.
Powder Free Vinyl Patient Examination Gloves
K142571 · Ever Light Plastic Products Co., Ltd. · Dec 2014
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored)
K142343 · Tangshan Hongyun Plastic Products Co., Ltd. · Dec 2014
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · Grand Work Plastic Products Co., Ltd. · Dec 2014
YONGHE
K140244 · Yonghe Plastic Products Co., Ltd. · Nov 2014
YONGFA
K140246 · Yongfa Glove Co., Ltd. · Nov 2014
YUSHENG
K141108 · Zibo Yusheng Plastic Products Co., Ltd. · Sep 2014
K141613 · GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
Download PDF FDA Summary Zibo Goldenline Plast…