Cleared Traditional

K143340 - Powder Free Vinyl Patient Examination Gloves, Yellow Color

K143340 is an FDA 510(k) clearance for Powder Free Vinyl Patient Examination G..., manufactured by Zibo Ling Yun Medical Products Co, Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K143340 · Zibo Ling Yun Medical Products Co, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
230d
Days
Class 1
Risk

K143340 is an FDA 510(k) clearance for the Powder Free Vinyl Patient Examination Gloves, Yellow Color. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Ling Yun Medical Products Co, Ltd. (Zibo, CN). The FDA issued a Cleared decision on July 9, 2015 after a review of 230 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 - K143340

510(k) Number K143340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2014
Decision Date July 09, 2015
Days to Decision 230 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
101d slower than avg
Panel avg: 129d · This submission: 230d
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

Basic Medical Industries., Inc.
RAY ZHOU

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 K143340.
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
K143277 · Lifestyle Safety Products (Hui Zhou) Co., Ltd. · Jul 2015
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, Clear (non-colored)
K143715 · Better Plastic Co., Ltd. · Jun 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