(45 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml ≥ 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes
Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Not recommended for use with these drugs.
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.
The provided document is a 510(k) Premarket Notification for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. It details the acceptance criteria and performance data for this medical device, which is a non-powdered patient examination glove.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥ 220, M/L/XL: ≥ 230 | |
| Width (mm): S: 80 ± 10, M: 95 ± 10, L: 110 ± 10, XL: 120 ± 10 | |||
| Thickness (mm): Finger: ≥ 0.05, Palm: ≥ 0.05 | Length (mm): S: ≥ 220 / Pass, M/L/XL: ≥ 230 / Pass | ||
| Width (mm): S: 82 – 85 / Pass, M: 95 – 97 / Pass, L: 103 – 107 / Pass, XL: 110 – 116 / Pass | |||
| Thickness (mm): Finger: 0.13 – 0.17 / Pass, Palm: 0.09 – 0.11 / Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | S: 1/125 / Pass, M: 2/125 / Pass, L: 2/125 / Pass, XL: 4/125 / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
§ 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.