Cleared Traditional

K990542 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

K990542 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 46-day FDA review.

K990542 · Brightway Holdings Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
46d
Days
Class 1
Risk

K990542 is an FDA 510(k) clearance for the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED). 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 April 9, 1999 after a review of 46 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 - K990542

510(k) Number K990542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date April 09, 1999
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 K990542.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
K990485 · Alliance Rubber Products Sdn. Bhd. · Apr 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
K990486 · Alliance Rubber Products Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541 · Brightway Holdings Sdn. Bhd. · Apr 1999
POWDER FREE NITRILE EXAMINATION GLOVES
K990495 · Flexitech Sdn. Bhd. · Apr 1999
PREPOWDERED NITRILE EXAMINATION GLOVES
K990499 · Flexitech Sdn. Bhd. · Apr 1999
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
K990267 · Shanghai Palomar Mountain Industries, Inc. · Mar 1999