OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE

• K Number: K990696
• Device Name: OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE
• Manufacturer: OMNIGRACE (THAILAND) LTD.
• Date Cleared: 1999-05-13 ( 71 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

Device Description

Omni Flex Nitrile Examination Glove, Powder Free

AI/ML Overview

I am sorry, but I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The documents are FDA 510(k) clearance letters and an "Indications For Use Statement" for an "Omni Flex Nitrile Examination Glove, Powder-Free".

These documents do not contain any information about performance studies, acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC).

The provided text primarily focuses on:

• Regulatory Clearance: The FDA's determination that the device is "substantially equivalent" to legally marketed predicate devices.
• Product Information: Device name, applicant, and intended use (as stated in the "Indications For Use Statement").
• Regulatory Requirements: Mention of general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.

To answer your request, I would need a different type of document, such as a clinical study report, a regulatory submission summary that includes performance data, or a publication detailing the device's validation.

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.