Cleared Traditional

K141304 - YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

K141304 is an FDA 510(k) clearance for YONGXIN NITRILE POWDER FREE PATIENT EXA..., manufactured by Yongxin Healthcare Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K141304 · Yongxin Healthcare Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
207d
Days
Class 1
Risk

K141304 is an FDA 510(k) clearance for the YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Yongxin Healthcare Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 12, 2014 after a review of 207 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.

View all Yongxin Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K141304

510(k) Number K141304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2014
Decision Date December 12, 2014
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 1165
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K141304.
Nitrile Powder Free Examination Glove (Blue)
K142588 · Hartalega Sdn Bhd · Dec 2014
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
K142805 · Hartalega Sdb. Bhd. · Dec 2014
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141303 · Zhida Glove Co., Ltd. · Dec 2014
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141279 · Wanghui Glove Co., Ltd. · Dec 2014
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
K141287 · Huikang Glove Co., Ltd. · Dec 2014
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141579 · Eco Medi Glove Sdn. Bhd. · Oct 2014