TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES

• K Number: K990577
• Device Name: TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
• Manufacturer: TA CHIA RUBBER IND. CORP.
• Date Cleared: 1999-05-04 ( 70 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Non-Sterile Nitrile Examination Gloves

AI/ML Overview

I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for patient examination gloves and focuses on regulatory approval rather than a detailed study description with acceptance criteria and performance metrics. Therefore, I cannot extract the specific details about acceptance criteria, study design, expert qualifications, or ground truth establishment that you are looking for.

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.