(160 days)
A powder-free 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.
In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below.
| No. | Chemotherapy Drugs and Concentrations | Breakthrough |
|---|---|---|
| 1. | Blenoxane (15 mg/ml) | > 240 minutes |
| 2. | Busulfan (6 mg/ml) | > 240 minutes |
| 3. | Carboplatin (10 mg/ml) | > 240 minutes |
| 4. | Carmustine (BCNU) (3.3 mg/ml)* | 30.4 minutes |
| 5. | Cisplatin (1.0 mg/ml) | > 240 minutes |
| 6. | Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| 7. | Cytarabine (100 mg/ml) | > 240 minutes |
| 8. | Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| 9. | Daunorubicin (5 mg/ml) | > 240 minutes |
| 10. | Docetaxel (10.0 mg/ml) | > 240 minutes |
| 11. | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| 12. | Ellence (2 mg/ml) | > 240 minutes |
| 13. | Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| 14. | Fludarabine (25 mg/ml) | > 240 minutes |
| 15. | Fluorouracil (50.0 mg/ml) | > 240 minutes |
| 16. | Ganciclovir (10 mg/ml) | > 240 minutes |
| 17. | Gemcitabine (Gemzar) (38 mg/ml) | > 240 minutes |
| 18. | Idarubicin (1 mg/ml) | > 240 minutes |
| 19. | Ifosfamide (50.0 mg/ml) | > 240 minutes |
| 20. | Irinotecan (20.0 mg/ml) | > 240 minutes |
| 21. | Mechlorethamine HCl (1.0 mg/ml) | > 240 minutes |
| 22. | Melphalan (5 mg/ml) | > 240 minutes |
| 23. | Methotrexate (25 mg/ml) | > 240 minutes |
| 24. | Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 25. | Mitomycin C (0.5 mg/ml) | > 240 minutes |
| 26. | Oxaliplatin (5 mg/ml) | > 240 minutes |
| 27. | Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| 28. | Rituximab (10 mg/ml) | > 240 minutes |
| 29. | Thiotepa (10.0 mg/ml) | > 240 minutes |
| 30. | Trisenox (0.1 mg/ml) | > 240 minutes |
| 31. | Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
| 32. | Vinorelbine (10 mg/ml) | > 240 minutes |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are non-sterile, lavender blue colored, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Chemotherapy drugs listed in the Intended Use(s) section below, as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
This document describes the "HG PRO XP® Nitrile Powder Free Examination Gloves Tested For Use with Chemotherapy Drugs" and its substantial equivalence to a predicate device (K113423). The study primarily focuses on non-clinical performance data, specifically addressing the glove's resistance to permeation by chemotherapy drugs and other physical and biological properties.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides a comprehensive side-by-side comparison in "Table 1. Side-by-Side Comparison of Predicate Device with Subject Device: Indications for Use, Non-clinical Performance Data and Technological Characteristics" (pages 7-8).
| Characteristics | Acceptance Criteria/Standards | Subject Device Performance |
|---|---|---|
| Primary Indication for Use | Medical Gloves Guidance Manual | A powder-free patient Examination Gloves 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. |
| Additional Indication (Chemo Drugs) | ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | Breakthrough Detection Time (min) for various chemotherapy drugs: |
- Blenoxane (15 mg/ml): > 240 min
- Busulfan (6 mg/ml): > 240 min
- Carboplatin (10 mg/ml): > 240 min
- Carmustine (BCNU) (3.3 mg/ml): 30.4 min
- Cisplatin (1.0 mg/ml): > 240 min
- Cyclophosphamide (Cytoxan) (20 mg/ml): > 240 min
- Cytarabine (100 mg/ml): > 240 min
- Dacarbazine (DTIC) (10.0 mg/ml): > 240 min
- Daunorubicin (5 mg/ml): > 240 min
- Docetaxel (10.0 mg/ml): > 240 min
- Doxorubicin Hydrochloride (2.0 mg/ml): > 240 min
- Ellence (2 mg/ml): > 240 min
- Etoposide (Toposar) (20.0 mg/ml): > 240 min
- Fludarabine (25 mg/ml): > 240 min
- Fluorouracil (50.0 mg/ml): > 240 min
- Ganciclovir (10 mg/ml): > 240 min
- Gemcitabine (Gemzar) (38 mg/ml): > 240 min
- Idarubicin (1 mg/ml): > 240 min
- Ifosfamide (50.0 mg/ml): > 240 min
- Irinotecan (20.0 mg/ml): > 240 min
- Mechlorethamine HCl (1.0 mg/ml): > 240 min
- Melphalan (5 mg/ml): > 240 min
- Methotrexate (25 mg/ml): > 240 min
- Mitoxantrone (2.0 mg/ml): > 240 min
- Mitomycin C (0.5 mg/ml): > 240 min
- Oxaliplatin (5 mg/ml): > 240 min
- Paclitaxel (Taxol) (6.0 mg/ml): > 240 min
- Rituximab (10 mg/ml): > 240 min
- Thiotepa (10.0 mg/ml): > 240 min
- Trisenox (0.1 mg/ml): > 240 min
- Vincristine Sulfate (1.0 mg/ml): > 240 min
- Vinorelbine (10 mg/ml): > 240 min
*Noted extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes. |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber |
| Color | - | Lavender Blue |
| Texture | - | Textured Fingers |
| Size | Medical Glove Guidance Manual-Labeling- Issued on January 22, 2008 | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Gloves Guidance Manual -Issued on January 22, 2008 | Single use |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 (Length: 270 mm minimum, Palm Widths for various sizes provided) |
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 (Finger: 0.10 mm minimum, Palm: 0.10 mm minimum) |
| Physical Properties | ASTM D6319-10 | Meet ASTM D6319-10 (Tensile Strength: 14 MPa min (before & after aging), Ultimate Elongation: 500% min (before aging), 400% min (after aging)) |
| Watertight test | ASTM D5151-06 | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet (
§ 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.