(78 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.
Nitrile Patient Examination Glove (Blue)
The provided documents are a 510(k) clearance letter from the FDA for a Nitrile Patient Examination Glove. This type of document is for the regulatory clearance of a medical device and does not contain information about acceptance criteria or a study proving device performance in the way requested in the prompt.
The prompt asks for details typically found in the clinical study section of a regulatory submission for a diagnostic algorithm, AI device, or other medical devices requiring performance evaluation against a specific clinical outcome or ground truth.
Therefore, I cannot provide the requested information from the given text.
The document details the following:
- Device Type: Nitrile Patient Examination Glove (Blue)
- Regulatory Class: I
- Product Code: LZA
- Indications For 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.
- Clearance Date: September 30, 1998
- Manufacturer: Perusahaan Getah Asas Sdn. Bhd.
To answer your prompt, I would need a clinical study report or a 510(k) submission that includes performance data for a device, such as a diagnostic algorithm or a measuring instrument, which would typically have acceptance criteria, sample sizes, ground truth establishment methods, and statistical analysis of performance.
§ 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.