(124 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, white colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured per ASTM D6319-10 standard and tested for use with chemotherapy drugs per ASTM D6978-05 (reapproved 2013).
The provided text describes the regulatory submission for the "Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)" and the testing conducted to support its claims, specifically its resistance to chemotherapy drugs.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the chemotherapy drug resistance are the breakthrough times for various chemotherapy drugs, as tested per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the minimum breakthrough time for each drug.
| Chemotherapy Drug Tested | Concentration | Acceptance Criteria (Implied by standard and results) | Reported Device Performance (Minimum Breakthrough Time) |
|---|---|---|---|
| Blenoxane | 15 mg/ml | Minimum acceptable time depends on risk assessment | >240 minutes |
| Bortezomib | 1 mg/ml | >240 minutes | |
| Busulfan | 6 mg/ml | >240 minutes | |
| Carmustine (BCNU) | 3.3 mg/ml | 11.9 minutes | |
| Cetuximab (Erbitux) | 2 mg/ml | >240 minutes | |
| Cisplatin | 1.0 mg/ml | >240 minutes | |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 minutes | |
| Cytarabine | 100 mg/ml | >240 minutes | |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 minutes | |
| Daunorubicin | 5 mg/ml | >240 minutes | |
| Docetaxel | 10.0 mg/ml | >240 minutes | |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | |
| Ellence | 2 mg/ml | >240 minutes | |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes | |
| Fludarabine | 25 mg/ml | >240 minutes | |
| Fluorouracil | 50.0 mg/ml | >240 minutes | |
| Gemcitabine (Gemzar) | 38 mg/ml | >240 minutes | |
| Idarubicin | 1 mg/ml | >240 minutes | |
| Ifosfamide | 50.0 mg/ml | >240 minutes | |
| Irinotecan | 20.0 mg/ml | >240 minutes | |
| Mechlorethamine HCI | 1.0 mg/ml | >240 minutes | |
| Melphalan | 5 mg/ml | >240 minutes | |
| Methotrexate | 25 mg/ml | >240 minutes | |
| Methotrexate | 50 mg/ml | >240 minutes | |
| Mitomycin C | 0.5 mg/ml | >240 minutes | |
| Mitoxantrone | 2.0 mg/ml | >240 minutes | |
| Oxaliplatin | 5 mg/ml | >240 minutes | |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes | |
| Paraplatin | 10 mg/ml | >240 minutes | |
| Pemetrexed Disodium | 25 mg/ml | >240 minutes | |
| Raltitrexed | 0.5 mg/ml | >240 minutes | |
| Rituximab | 10 mg/ml | >240 minutes | |
| Thiotepa | 10.0 mg/ml | 18.6 minutes | |
| Trisonex | 0.1 mg/ml | >240 minutes | |
| Vidaza (5-Azacytidine) | 25 mg/ml | >240 minutes | |
| Vinblastine | 1 mg/ml | >240 minutes | |
| Vinorelbine | 10 mg/ml | >240 minutes | |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes |
Other acceptance criteria are derived from ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application, including:
| Characteristic | Acceptance Criteria (ASTM D6319-10 minimum) | Reported Device Performance |
|---|---|---|
| Length | 230mm min. | Complies (230mm min.) |
| Width | X-small – 70±10mm, Small – 80±10mm, Medium – 95±10mm, Large – 110±10mm, X-large – 120±10mm | Complies |
| Thickness | Palm – 0.05mm min., Finger – 0.05mm min. | Complies |
| Tensile Strength | Before Aging ≥14 MPa, min.; After Aging ≥14 MPa, min. | Complies |
| Elongation | Before Aging 500%, min.; After Aging 400%, min. | Complies |
| Freedom from Holes | G-1, AQL 1.5 (per ASTM D6319-10 and ASTM D5151-06) | Complies |
| Residual Powder |
§ 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.