(134 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.
| Characteristic | Acceptance Criteria (Standard) | Blue Glove Performance (Reported) | Cobalt Blue Glove Performance (Reported) |
|---|---|---|---|
| Chemotherapy Permeation (ASTM D6978-05) | (Comparison to predicate and general clinical expectation of protection) | See detailed table below | See detailed table below |
| Carboplatin, 10mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Carmustine, 3.3mg/ml | No specific numerical acceptance listed | 15.0 minutes | 2.4 minutes |
| Cisplatin, 1.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Cyclophosphamide, 20.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Dacarbazine, 10.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Doxorubicin HCl, 2.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Etoposide, 20.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Fluorouracil, 50.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Ifosfamide, 50.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Methotrexate, 25mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Mitomycin C, 0.5mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Mitoxantrone, 2mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Paclitaxel, 6.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| ThioTEPA, 10.0mg/ml | No specific numerical acceptance listed | 30.1 minutes | 1.9 minutes |
| Vincristine Sulfate, 1.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Physical (ASTM D6319-10) | Meets ASTM D6319-10 specifications | Meets | Meets |
| Dimension (Length) | Min 240mm (ASTM D6319-10) | Min 240mm | Min 240mm |
| Thickness (Finger) | No specific numerical acceptance for subject devices listed, predicate 0.03-0.05mm | 0.03mm min | 0.03mm min |
| Thickness (Palm) | No specific numerical acceptance for subject devices listed, predicate 1.5-0.08mm | 0.05mm min | 0.05mm min |
| Thickness (Cuff) | No specific numerical acceptance for subject devices listed, predicate 1.6-0.09mm | 0.05mm min | 0.05mm min |
| Powder-free |
§ 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.