(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 ( |
§ 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.