Cleared Traditional

K022878 - BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)

K022878 is an FDA 510(k) clearance for BRIGHTWAY BRAND COLORED POWDER FREE NIT..., 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 18-day FDA review.

K022878 · Brightway Holdings Sdn. Bhd. · General Hospital
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Sep 2002
Decision
18d
Days
Class 1
Risk

K022878 is an FDA 510(k) clearance for the BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE). 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 September 17, 2002 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brightway Holdings Sdn. Bhd. devices

FDA 510(k) Submission Details - K022878

510(k) Number K022878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date September 17, 2002
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 K022878.
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K022781 · Industrial Clothings, Ltd. · Oct 2002
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
K022904 · Wrp Asia Pacific Sdn. Bhd. · Oct 2002
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K022818 · Smart Glove Corp. Sdn Bhd · Sep 2002
POWDER FREE NITRILE EXAMINATION GLOVES
K022619 · Ar Alliance Healthcare Sdn. Bhd. · Sep 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · Syntex Healthcare Products Co., Ltd. · Sep 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
K022102 · Latexx Manufacturing Sdn.Bhd. · Aug 2002