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510(k) Data Aggregation
(255 days)
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device Intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs. Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.
The device, "Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)," demonstrated compliance through a series of non-clinical performance studies. The studies assessed the gloves against various ASTM standards and internal performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
CHARACTERISTICS | STANDARDS / Acceptance Criteria | Reported Device Performance |
---|---|---|
Dimensions | ASTM D3578-01E1 | Meets |
Physical Properties | ASTM D3578-01E1 | Meets |
Thickness | ASTM D3578-01E1 | Meets |
Powder Free | ASTM D6124-01 | Meets (≤ 2 mg/glove) |
Protein Level | ASTM D5712-95 | Meets ( |
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