Cleared Traditional

K990878 - BRIGHTWAY BRAND BLUE NITRILE EXAMINATIO...

K990878 is an FDA 510(k) clearance for BRIGHTWAY BRAND BLUE NITRILE EXAMINATIO..., 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 66-day FDA review.

K990878 · Brightway Holdings Sdn. Bhd. · General Hospital
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May 1999
Decision
66d
Days
Class 1
Risk

K990878 is an FDA 510(k) clearance for the BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE). 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 May 21, 1999 after a review of 66 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 - K990878

510(k) Number K990878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1999
Decision Date May 21, 1999
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K990878.
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
K991615 · Maxxim Medical · Jul 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · Brightway Holdings Sdn. Bhd. · Jun 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
K990882 · La Glove (M) Sdn. Bhd. · May 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840 · Terang Nusa Sdn Bhd · May 1999
NUGARD NITRIL NITRILE EXAMINATION GLOVE
K990841 · Terang Nusa Sdn Bhd · May 1999