Cleared Traditional

K032938 - BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER

K032938 is an FDA 510(k) clearance for BRIGHTWAY BRAND LATEX EXAMINATION GLOVE..., 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 59-day FDA review.

K032938 · Brightway Holdings Sdn. Bhd. · General Hospital
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Nov 2003
Decision
59d
Days
Class 1
Risk

K032938 is an FDA 510(k) clearance for the BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 U.... 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 November 20, 2003 after a review of 59 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 - K032938

510(k) Number K032938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date November 20, 2003
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 912
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K032938.
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
K033530 · Asia Pacific Latex Sdn Bhd · Jan 2004
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K033532 · Asia Pacific Latex Sdn Bhd · Jan 2004
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
K023537 · Sgmp Co., Ltd. · Nov 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
K032940 · Brightway Holdings Sdn. Bhd. · Nov 2003
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
K030583 · Shen Wei (Usa), Inc. · Nov 2003
POWDER FREE LATEX EXAM GLOVES
K031335 · Tan Sin Lian Industries Sdn. Bhd. · Oct 2003