(260 days)
A patient examination 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 56.9 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 119.2 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes
Please note that the following drug has low permeation times: Carmustine (BCNU) (3.3 mg/ml) 56.9 minutes Thiotepa (10.0 mg/ml) 119.2 minutes
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This document is a 510(k) clearance letter for Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs). It does not contain any information about a study proving device performance against acceptance criteria for a medical device that uses AI or machine learning.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
- Regulatory information regarding the marketing and sale of the device.
- The Indications for Use for the gloves, specifically mentioning that they were tested for use with chemotherapy drugs as per ASTM D6978-05. The permeation times for various chemotherapy drugs are listed.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or AI/ML-related performance metrics, as this document does not pertain to such a device or 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.