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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol)

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Powder Free Latex Examination Gloves, Blue Tested For Use With Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Latex Examination Gloves, Blue Tested for Use With Chemotherapy Drugs".

The document does not contain any information regarding acceptance criteria for a study, reported device performance, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, this letter is an administrative notification that indicates the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, regulation name, product code, and the indications for use. It also outlines the manufacturer's responsibilities under the Act.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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