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510(k) Data Aggregation
(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 (< 2.0 mg/glove) |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10: 2010 | Pass (Not a primary skin irritant under the conditions of the study) |
| Biocompatibility | Dermal Sensitization - ISO 10993-10: 2010 | Pass (Not a contact sensitizer under the conditions of the study) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the sample size (e.g., number of gloves) used for each specific test (e.g., watertight, chemotherapy permeation). It refers to compliance with standards like ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, and ASTM D6978-05, which would typically specify the required sample sizes for testing. For example, for the watertight test, it states "Pass AQL 1.5," which implies statistical sampling and testing according to the ASTM D5151-06 standard.
- Data Provenance: The manufacturer is "Healthy Glove Co., Ltd" from Hatyai, Songkhla, Thailand (page 4). The data itself is "non-clinical performance data" (page 10) generated to show substantial equivalence to a predicate device. It is prospective testing conducted by the manufacturer or contracted labs to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This type of information is not applicable to this submission. The device is a patient examination glove, and the "ground truth" is established by adherence to recognized international and national standards (ASTM, ISO) for material properties, physical performance, biocompatibility, and chemical resistance. These standards define objective test methods and acceptance criteria, rather than relying on expert human interpretation of complex medical imagery or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., medical imaging reads) where discrepancies need to be resolved. For objective physical and chemical testing of medical gloves, the results are quantitative or pass/fail based on the defined test methodologies of the respective ASTM and ISO standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This device is a medical glove, not an AI-powered diagnostic or interpretive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or assessment of human reader improvement with AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical product (medical glove), not an algorithm or software. Standalone performance for an algorithm is not relevant here. The "standalone" performance here refers to the glove's inherent properties and performance tested against predefined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device is based on accepted industry standards and test methods. Specifically:
- Physical properties (dimensions, thickness, tensile strength, elongation) are compared against ASTM D6319-10.
- Watertight integrity is assessed per ASTM D5151-06.
- Residual powder is measured per ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is tested according to ISO 10993-10:2010.
- Resistance to chemotherapy drug permeation is tested according to ASTM D6978-05.
These standards define the methodologies and the acceptable ranges for performance, serving as the objective "ground truth."
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The glove manufacturer produces the gloves, and then specific samples are tested for compliance with standards. There's no iterative learning or model training involved.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant. The "ground truth" for evaluating the glove's performance against its acceptance criteria is established by the test protocols within the cited ASTM and ISO standards.
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