(57 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves (White, Blue, Purple)
The provided text is a 510(k) premarket notification letter from the FDA to PT. Smart Glove Indonesia regarding powdered-free nitrile examination gloves. This type of document is for a medical device and not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI/ML specific evaluations (like MRMC studies, standalone performance, training set details) is not applicable and cannot be extracted from this document.
The document confirms that:
- Device Name: Powder Free Nitrile Examination Gloves (White, Blue, Purple)
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I
- Product Code: LZA
- Indication For Use: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the safety and effectiveness standards of similar devices already on the market. However, this determination is based on a comparison to predicate devices and typically involves testing against established industry standards for barrier protection, biocompatibility, and physical properties of gloves, not AI/ML performance metrics.
To answer your specific questions in the context of this general medical device, I can only state that the information you're asking for is not present because it pertains to AI/ML devices, which this is not.
§ 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.