(241 days)
Indications for Use (Describe) CAUTION: Testing showed an average breakthrough time of 39.1 minutes for Thiotepa. WARNING: Do not use with Carmustine.
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
This document does not contain any information about acceptance criteria or a study related to a medical device's performance.
The provided text is a 510(k) clearance letter from the FDA to Shen Wei USA Inc. for their "Biodegradable Powder Free Nitrile Examination Glove." This letter states that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.
The document includes:
- FDA 510(k) clearance letter: This is a regulatory approval, not a performance study report.
- Indications for Use statement: This describes the intended use of the gloves, including precautions regarding specific chemotherapy drugs (Thiotepa and Carmustine).
- Paperwork Reduction Act (PRA) statement: This is a administrative notice.
There is no mention of:
- A table of acceptance criteria or reported device performance for any AI/software device.
- Sample sizes for test sets, data provenance, or ground truth.
- Expert involvement or adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot provide the requested information based on the given input.
§ 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.