(68 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Syntex Powder-Free Latex Examination Glove
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification letter from the FDA to Syntex Healthcare Product Company Limited regarding their "Syntex Powder-Free Latex Examination Glove".
This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device and can be marketed. However, it does not include details about:
- Acceptance criteria: There is no table of specific performance metrics or a detailed description of what constitutes "acceptance."
- Reported device performance: The letter does not contain any test results, data, or performance statistics for the Syntex glove.
- Study details: There is no mention of a specific study, its design, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets.
The letter primarily focuses on the regulatory decision of substantial equivalence and general compliance requirements. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSD), a clinical study report, or a more detailed 510(k) submission document that typically includes performance data.
§ 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.