(36 days)
A 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.
Powder-free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
The provided text is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove. This document confirms that the device is substantially equivalent to a predicate device already on the market and does not require an approval for a premarket approval application (PMA).
The document does not detail any studies, acceptance criteria, or performance metrics for the device. It is a regulatory letter of approval based on the substantial equivalence principle, rather than a report on device performance testing. As such, I cannot provide the requested information from the given text.
The information I can extract directly from the provided text is:
- Device Name: Powder-Free Nitrile Patient Examination Glove, White (non-colored), Blue and Green Colored
- Intended Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
- Regulatory Class: I
- Product Code: LZA
- Regulation Number: 880.6250 (Patient Examination Gloves)
§ 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.