Cleared Traditional

K163126 - Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)

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.

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
Combination Product No
PCCP Authorized No
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 1176
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K163126.
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982 · Medline Industries, Inc. · Feb 2017
Powder Free Nitrile Examination Gloves, Black
K161099 · Pt. Maja Agung Latexindo · 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
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
K162381 · Healthy Glove Co., Ltd. · Jan 2017