(259 days)
The Skybreeze Zero Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml), Carmustine (3.3 mg/ml), ThioTEPA (10.0 mg.ml). Warning: Not for Use with: Carmustine, ThioTEPA.
The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs are disposable, blue-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves packed in a cardboard dispenser box.
The provided text is related to the 510(k) premarket notification for "SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs." This document outlines the safety and performance characteristics of medical exam gloves, not artificial intelligence (AI) software. As such, information regarding AI-specific criteria like multi-reader multi-case (MRMC) studies, sample sizes for AI training sets, or the number of experts for AI ground truth establishment is not present.
However, I can extract information related to the acceptance criteria and studies for the medical exam gloves as described in the document.
1. A table of acceptance criteria and the reported device performance:
| Standard / Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6978-05: Resistance to Permeation by Chemotherapy Drugs | No breakthrough for specified drugs for a certain duration (implicitly, as good as or better than predicate). | - No breakthrough up to 240 minutes for: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml). |
- Breakthrough detected at: Carmustine (3.3 mg/ml) - 18.6 minutes, ThioTEPA (10.0 mg/ml) - 48.3 minutes.
Result: Meets acceptance criteria for 10 drugs. |
| ASTM D5151-06: Detection of Holes in Medical Gloves | Meets 2.5% AQL requirement for leakage. | Testing of the subject device shows it meets the 2.5% AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. |
| ASTM D6124-06: Residual Powder on Medical Gloves |
§ 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.