(93 days)
The Glove Seal D'Pro Latex Examination glove is a disposable patient examination glove that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Glove Seal D'Pro Latex Examination Glove, Powdered with 100 mcgm or Less of Total Water Extractable Protein Per Gram
The provided text is a 510(k) clearance letter from the FDA for a latex examination glove. This type of document does not contain the acceptance criteria or a study description as typically found for complex AI/ML-driven medical devices.
The FDA 510(k) clearance process for devices like examination gloves primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves:
- Performance Standards: Glov_es are subject to various ASTM standards regarding tensile strength, elongation, barrier integrity (pinholes), and often protein levels for latex gloves to address allergic reactions.
- Biocompatibility: Tests to ensure the materials are not harmful to human tissue.
- Labeling and Manufacturing: Adherence to good manufacturing practices (GMP) and appropriate labeling.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and study details as it pertains to AI/ML device evaluations. The document relates to a simple medical device (examination glove) and its regulatory clearance process, which does not involve AI performance studies.
§ 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.