(253 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 drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 and FDA 21 CFR 880.6250.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Blue Latex Patient Examination Gloves:
This document is a 510(k) summary for a medical device (examination gloves), which primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards. Therefore, the "study" described is a series of compliance tests rather than a clinical trial or a typical algorithmic performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | Acceptance Criteria (Standards) | Reported Device Performance (Current Device) |
|---|---|---|
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Thickness | ASTM D3578-05 | Meets |
| Powder Free | ASTM D6124-06 | 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.