Cleared Traditional

K143715 - Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K143715 is an FDA 510(k) clearance for Powder Free Vinyl Patient Examination G..., manufactured by Better Plastic Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K143715 · Better Plastic Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
158d
Days
Class 1
Risk

K143715 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Better Plastic Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on June 5, 2015 after a review of 158 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 - K143715

510(k) Number K143715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date June 05, 2015
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 739
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K143715.
Powder-Free Yellow Vinyl Patient Examination Gloves
K143347 · Zibo Zhouheng Plastic Products Co., Ltd. · Jul 2015
Powder-Free White Vinyl Patient Examination Gloves
K143346 · Zibo Changda Plastic Products Company, Limited · Jul 2015
Powder Free Vinyl Patient Examination Gloves, Yellow Color
K143340 · Zibo Ling Yun Medical Products Co, Ltd. · Jul 2015
BLUE VINYL GLOVES POWDER FREE
K150224 · Zibo Sanying Trade Co., Ltd. · May 2015
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142911 · Huailai ZM Plastic Products Co., Ltd. · Apr 2015
Powder-free Clear Vinyl Patient Examination Gloves
K142892 · Shenyi (Shandong) Plastic Products Co., Ltd. · Mar 2015
K143715 · Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Download PDF FDA Summary Better Plastic Co., L…