(137 days)
This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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 Latex Examination Gloves with Protein Labelling Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification from the FDA, and it does not contain the detailed information about acceptance criteria and study results typically found in a clinical study report or a premarket approval (PMA) application. It focuses on the substantial equivalence of the device (Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim) to a predicate device.
Therefore, I cannot provide answers to most of your questions based solely on the provided text. The document does not describe the specific testing or studies performed to demonstrate the "50 Microgram or Less" protein content claim or other performance criteria.
However, I can extract the following limited information:
- Device Name: Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Microgram or Less)
- Product Code: LYY
- Indications For Use: "This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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." This indication explicitly includes the protein content claim of "50 Micrograms or less," which functions as a performance acceptance criterion for the device's labeling claim.
To answer your full set of questions, one would need to consult the actual 510(k) submission document, which would include the testing protocols and results that support the claims made about the device, particularly the protein content.
In summary, based on the provided text, I can only state that a key performance claim, and therefore a de-facto acceptance criterion for labeling, is a latex protein content of "50 Micrograms or less." The document does not include a study description, sample sizes, expert details, or other specifics of how this criterion was met.
§ 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.