Cleared Traditional

K162294 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K162294 is an FDA 510(k) clearance for BRIGHTWAY BRAND NITRILE EXAMINATION GLO..., 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 249-day FDA review.

K162294 · Brightway Holdings Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
249d
Days
Class 1
Risk

K162294 is an FDA 510(k) clearance for the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED .... 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 April 21, 2017 after a review of 249 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 - K162294

510(k) Number K162294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2016
Decision Date April 21, 2017
Days to Decision 249 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
120d slower than avg
Panel avg: 129d · This submission: 249d
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 1172
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162294.
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
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K161929 · Dipped Products (Thailand) Limited · Mar 2017
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K162405 · Comfort Rubber Gloves Industries Sdn. Bhd. · Mar 2017