Cleared Traditional

K011728 - BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (

K011728 is an FDA 510(k) clearance for BRIGHTWAY BRAND POWDER FREE LATEX EXAMI..., manufactured by Brightway Holdings Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K011728 · Brightway Holdings Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
35d
Days
Class 1
Risk

K011728 is an FDA 510(k) clearance for the BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTE.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Brightway Holdings Sdn. Bhd. (Klang, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on July 9, 2001 after a review of 35 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 - K011728

510(k) Number K011728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date July 09, 2001
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 913
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K011728.
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
K011712 · Pt.Shamrock Manufacturing Corp. · Jul 2001
POWDER FREE LATEX EXAMINATION GLOVES
K010546 · Jb Star Sdn Bhd · Jul 2001
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
K011293 · Multisafe Sdn. Bhd. · Jul 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
K011895 · Pwa Industries Sdn. Bhd. · Jul 2001
POWDERED LATEX EXAMINATION GLOVES
K011922 · Seltom Pacific Sdn. Bhd. · Jul 2001
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
K010854 · Protection Gloves Sdn. Bhd. · Jun 2001