Cleared Traditional

K163126 - Powder Free Nitrile Examination Gloves ...

K163126 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Blue Sail Medical Co.,Ltd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K163126 · Blue Sail Medical Co.,Ltd · General Hospital
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Feb 2017
Decision
106d
Days
Class 1
Risk

K163126 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Coba.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Blue Sail Medical Co.,Ltd (Zibo, CN). The FDA issued a Cleared decision on February 22, 2017 after a review of 106 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.

View all Blue Sail Medical Co.,Ltd devices

FDA 510(k) Submission Details - K163126

510(k) Number K163126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date February 22, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
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 730
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K163126.
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646 · Hartalega NGC Sdn. Bhd. · Mar 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982 · Medline Industries, Inc. · Feb 2017
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
K163041 · Pt. Medisafe Technologies · Feb 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · Hartalega Sdn Bhd · Feb 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
K162923 · Hartalega NGC Sdn. Bhd. · Feb 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K162818 · Hartalega Sdn Bhd · Jan 2017