POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR

• K Number: K141021
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
• Manufacturer: HL RUBBER INDUSTRIES SDN BHD
• Date Cleared: 2014-08-26 ( 127 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

A powder-free 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.

Device Description

Powder Free Nitrile Examination Gloves, Orange Color

AI/ML Overview

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving that a device meets such criteria.

The document is an FDA 510(k) clearance letter for "Powder-Free Nitrile Examination Gloves, Orange Color" (K141021). This letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new Premarket Approval Application (PMA).

The letter primarily focuses on:

• The trade/device name and regulation information.
• The substantial equivalence determination.
• General controls and regulations applicable to the device.
• Contact information for FDA guidance.
• The "Indications for Use" for the gloves, which defines their intended medical purpose.

There are no details about:

• Specific performance acceptance criteria for the gloves (e.g., tensile strength, puncture resistance, barrier integrity metrics).
• Any study (clinical or non-clinical) that was conducted to demonstrate performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment, experts, or adjudication methods.
• MRMC studies or standalone algorithm performance, as these gloves are a physical medical device, not an AI or software device.

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.