(87 days)
The Nittile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table.
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
I am sorry, but the provided text from the FDA 510(k) summary for the Nitrile Powder Free Examination Glove does not contain the information required to describe the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML medical device.
The document is a clearance letter for a physical medical device (examination gloves) and discusses aspects like:
- Substantial equivalence to predicate devices
- Regulatory classification (Class I)
- General controls like annual registration, listing, GMP, labeling, etc.
- Indications for Use for the glove, specifically mentioning its use with certain chemotherapy drugs and breakthrough times.
The questions you've asked (about sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are specific to the validation of AI/ML-based medical devices, often requiring performance metrics like sensitivity, specificity, AUC, or other clinical outcomes.
This document does not contain any information related to:
- AI/ML algorithms
- Image analysis or diagnostics
- Data sets for training or testing AI models
- Expert reader studies for AI validation
Therefore, I cannot extract the requested information from this document.
§ 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.