Cleared Traditional

K060402 - BRIGHTWAY BRAND NITRILE EXAMINATION GLO...

K060402 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 114-day FDA review.

K060402 · Brightway Holdings Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
114d
Days
Class 1
Risk

K060402 is an FDA 510(k) clearance for the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Brightway Holdings Sdn. Bhd. (Klang, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on June 9, 2006 after a review of 114 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 Brightway Holdings Sdn. Bhd. devices

FDA 510(k) Submission Details - K060402

510(k) Number K060402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2006
Decision Date June 09, 2006
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 K060402.
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
K061724 · Smart Glove Corp. Sdn Bhd · Jul 2006
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
K061553 · Yty Industry (Manjung) Sdn Bhd · Jul 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · Hartalega Sdn Bhd · Jun 2006
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR)
K060726 · Smart Glove Corp. Sdn Bhd · May 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
K060724 · Smart Glove Corp. Sdn Bhd · May 2006