(213 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs.
Nitrile Examination Powder Free Glove, White, Black, Orange Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
This document is a 510(k) premarket notification clearance letter for several types of Nitrile Examination Powder Free Gloves. It does not describe an AI/ML device or a medical imaging device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications is not applicable to this document.
The document primarily focuses on the regulatory clearance for general medical gloves and a specific type tested for chemotherapy drug permeation. The information provided relates to:
- Device Names: Nitrile Examination Powder Free Glove (White, Black, Orange) and Nitrile Examination Powder Free Glove Tested for Use with Chemotherapy Drugs (Blue).
- Intended Use: Disposable device worn on the examiner's hand to prevent contamination between patient and examiner.
- Regulatory Classification: Class I, Product Code LZA, LZC.
- Chemotherapy Drug Permeation Data (for the blue gloves only): A table listing chemotherapy drugs, their concentrations, and breakthrough detection times as per ASTM D6978-05 standard. This is the only "performance data" presented, showing how long it takes for a chemotherapy drug to permeate the glove.
Since this document pertains to physical medical devices (gloves) and not software or imaging devices, the specific questions about AI/ML performance metrics, studies, and ground truth establishment are not relevant.
§ 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.