Cleared Traditional

K161215 - Brightway Brand Nitrile Examination Gloves

K161215 is an FDA 510(k) clearance for Brightway Brand Nitrile Examination Gloves, manufactured by Brightway Holdings Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K161215 · Brightway Holdings Sdn. Bhd. · General Hospital
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Dec 2016
Decision
236d
Days
Class 1
Risk

K161215 is an FDA 510(k) clearance for the Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Test.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Brightway Holdings Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on December 21, 2016 after a review of 236 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 Brightway Holdings Sdn. Bhd. devices

FDA 510(k) Submission Details - K161215

510(k) Number K161215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date December 21, 2016
Days to Decision 236 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
107d slower than avg
Panel avg: 129d · This submission: 236d
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 724
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K161215.
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
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
K161932 · Terang Nusa Sdn Bhd · Nov 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074 · Shen Wei (Usa), Inc. · Nov 2016
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
K162095 · Yty Industry (Manjung) Sdn Bhd · Nov 2016