(186 days)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Nitrile Examination Gloves
I apologize, but the provided text from the FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves" does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way you've outlined in your request.
The document is a standard FDA clearance letter for a Class I medical device. It primarily discusses:
- Device Name: Disposable Medical Nitrile Examination Gloves
- Regulation Number and Name: 21 CFR 880.6250, Non-Powdered Patient Examination Glove
- Regulatory Class: Class I, reserved
- Product Code: LZA
- Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
- General Controls Provisions: Listing requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Indications for Use: Disposable device intended for medical purpose worn on the examiner's hand to prevent contamination between patient and examiner.
There is no mention of an AI/algorithm-based medical device, deep learning models, clinical validation studies, reader studies (MRMC), or any of the specific technical details you've requested (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, or effect sizes for human readers with AI assistance).
Therefore, I cannot fulfill your request with the provided input. The information you're asking for would typically be found in detailed premarket notification submissions, clinical study reports, or performance testing summaries, which are not part of this specific FDA clearance letter.
§ 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.