(209 days)
A 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. These gloves were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.
Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs
This document describes the acceptance criteria and the study results for the "Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs".
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for gloves used with chemotherapy drugs are typically based on the "breakthrough detection time" of various chemotherapy drugs as per ASTM D6978-05. While the document doesn't explicitly state a minimum acceptance time for all drugs (other than the general implication that a longer breakthrough time is better), the reported performance indicates that breakthrough times greater than 240 minutes are considered acceptable for most. However, two drugs showed significantly shorter breakthrough times, which the manufacturer highlights with a warning.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes (Acceptance Criteria Implicitly >240 min for safe use) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine (BCNU), 3.3mg/ml | Not explicitly defined, but 240 | >240 |
| 3. Cyclophosphamide (Cytoxan), 20mg/ml | >240 | >240 |
| 4. Dacarbazine (DTIC) 10mg/ml | >240 | >240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| 6. Etoposide (Toposar), 20mg/ml | >240 | >240 |
| 7. Fluorouracil 50mg/ml | >240 | >240 |
| 8. Paclitaxel (Taxol), 6.0mg/ml | >240 | >240 |
| 9. Thiotepa, 10mg/ml | Not explicitly defined, but |
§ 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.