Cleared Traditional

K162924 - Nitrile Powder Free Examination Gloves ...

Also marketed or referenced as:
Dark Violet Blue (DVBU) Dark Blue (DKBU)

K162924 is an FDA 510(k) clearance for Nitrile Powder Free Examination Gloves ..., manufactured by Hartalega Sdb. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K162924 · Hartalega Sdb. Bhd. · General Hospital
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Jan 2017
Decision
98d
Days
Class 1
Risk

K162924 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdb. Bhd. (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on January 24, 2017 after a review of 98 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 Hartalega Sdb. Bhd. devices

FDA 510(k) Submission Details - K162924

510(k) Number K162924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2016
Decision Date January 24, 2017
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 733
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162924.
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
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K162819 · Hartalega Sdn Bhd · Jan 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K162146 · Brightway Holdings Sdn. Bhd. · Jan 2017