(88 days)
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Analysis of Information Provided:
The provided document is an FDA 510(k) clearance letter for a "Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)". This document pertains to regulatory approval for a medical device that falls under the category of patient examination gloves.
The content of this document does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The document is a regulatory approval for a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, general controls, and compliance with specific FDA regulations for such devices.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for an AI/ML device from this particular document.
Summary of Device and Approval:
- Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: I
- Product Code: LZA
- Approval Type: 510(k) Premarket Notification (substantial equivalence)
- Indications for Use: Non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
- Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)
Conclusion regarding requested AI/ML study information:
The provided document is irrelevant to the request about acceptance criteria and studies for an AI/ML device. It is a regulatory approval for a physical medical glove.
§ 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.