Cleared Traditional

K150224 - BLUE VINYL GLOVES POWDER FREE

K150224 is an FDA 510(k) clearance for BLUE VINYL GLOVES POWDER FREE, manufactured by Zibo Sanying Trade Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K150224 · Zibo Sanying Trade Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
99d
Days
Class 1
Risk

K150224 is an FDA 510(k) clearance for the BLUE VINYL GLOVES POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Zibo Sanying Trade Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on May 12, 2015 after a review of 99 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 - K150224

510(k) Number K150224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date May 12, 2015
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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

Beijing Believe Tech.Service Co., Ltd.
Ray Wang

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 K150224.
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
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K143715 · Better Plastic Co., Ltd. · Jun 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
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K141224 · Shijiazhunag Jiuyuan Plastic Co., Ltd. · Jan 2015