OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED

• K Number: K973134
• Device Name: OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
• Manufacturer: OMNIGRACE LTD.
• Date Cleared: 1997-11-06 ( 77 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• 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 healthcare personnel and the patient.

Device Description

Patient Examination Glove - Om Ni. FIT , LATEx TownEzFil EXAMINATION GLOVE.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (OMNI Fit Latex Examination Glove, Powdered). The provided text describes the regulatory approval process and states the intended use of the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—which are typically found in a clinical study report or a more detailed section of a 510(k) submission that discusses performance data.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Regulatory Status: That the FDA has reviewed the 510(k) and determined the device is substantially equivalent to predicate devices.
• Device Classification: Class I.
• General Controls: Mentioning requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: For regulatory advice.
• Indications for Use: Stating that the glove is "worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."

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.