POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN

• K Number: K091151
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
• Manufacturer: GX CORPORATION SDN BHD
• Date Cleared: 2009-06-01 ( 42 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powder Free Nitrile Examination Gloves, Green Tea Scented, Green

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for Powder Free Nitrile Examination Gloves. This letter does not contain information about acceptance criteria for a device's performance based on a study, but rather a determination of substantial equivalence to legally marketed predicate devices.

The document discusses:

• The review of a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Green Tea Scented, Green."
• The FDA's determination that the device is substantially equivalent to predicate devices.
• The classification of the device (Class I, Patient Examination Glove, Product Code LZA).
• Responsibilities of the manufacturer under the Act (e.g., registration, listing, labeling, GMP).
• Indications for Use: "This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."

Therefore, it is impossible to extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth from this document. This type of information would typically be found in the submitted 510(k) summary or detailed test reports, not the FDA's decision letter itself.

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.