Cleared Traditional

K140322 - WHITE VINYL EXAM GLOVES POWDER FREE

K140322 is an FDA 510(k) clearance for WHITE VINYL EXAM GLOVES POWDER FREE, manufactured by Shandong Dawei 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 122-day FDA review.

K140322 · Shandong Dawei Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
122d
Days
Class 1
Risk

K140322 is an FDA 510(k) clearance for the WHITE VINYL EXAM GLOVES POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shandong Dawei Medical Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on June 12, 2014 after a review of 122 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 - K140322

510(k) Number K140322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date June 12, 2014
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
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 K140322.
JIAWANG
K140239 · Jiawang Glove Co., Ltd. · Jun 2014
ZHAOFENG
K140240 · Zhaofeng Glove Co., Ltd. · Jun 2014
FEIYUE
K140242 · Feiyue Glove Co., Ltd. · Jun 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K122656 · Shandong Yifan Plastic Products Co., Ltd. · May 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K132637 · Zibo Intco Medical Products Co., Ltd. · May 2014
POWDERED VINYL EXAMINATION GLOVES
K122176 · Shu Tong Xinghua Co., Ltd. · Apr 2014
K140322 · WHITE VINYL EXAM GLOVES POWDER FREE
Download PDF FDA Summary Shandong Dawei Medica…