(273 days)
The device is intended as a protective device to be worn on the hands of healthcare or similar personnel to prevent cross-contamination between the wearer and the person being examined.
Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (containing a 100 micrograms or less of total water extractable protein per gram) and made from Allotex an Enzyme Treated Natural Rubber Latex.
I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.
The document is a US FDA 510(k) clearance letter for "Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves". This type of letter primarily indicates that the device has been found substantially equivalent to a predicate device already on the market, meaning no new clinical studies proving performance against acceptance criteria are typically required or detailed in the clearance letter itself.
The letter focuses on regulatory compliance, legal marketing, and general controls. It does not contain information on:
- Specific acceptance criteria for device performance (e.g., tensile strength, elongation, barrier integrity, protein levels in a performance study context).
- Any studies conducted to prove the device meets such criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
The closest relevant information is the "Protein Labeling Claim (containing a 100 micrograms or less of total water extractable protein per gram)", which is a device characteristic, but the document does not describe a study proving compliance with this specific limit.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or details about the study.
§ 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.