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

• K Number: K032938
• Device Name: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
• Manufacturer: BRIGHTWAY HOLDINGS SDN. BHD.
• Date Cleared: 2003-11-20 ( 59 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, sterile) containing 150 ugm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.

Device Description

BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or less of water extractable protein per gram.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for "Brightway Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or Less of water Extractable Protein Per Gram." This type of document is for a medical device that does not involve software or an AI algorithm, and therefore, the requested information about acceptance criteria for an AI device, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance is not applicable to this document.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements for the physical medical device (gloves). It does not contain any performance data, clinical study results, or information related to acceptance criteria for an artificial intelligence or machine learning model.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.