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(243 days)
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable devices 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 the following chemotherapy drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution as per ASTM -D6978-05 : The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCI (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 mg/ml) Mechlorethamine HCl (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliptin (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml) The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes. The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution Warning: Not for Use With: Carmustine, ThioTEPA
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution are disposable, lavender colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves. These gloves will be available in sizes Extra Small, Small, Medium, Large and Extra Large.
The document describes the acceptance criteria and performance of the "Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Meets requirements | |
| Length | 295 – 325 mm | Within limits of the standard | |
| Palm Width Size | X-Small: 60 – 80 mm; Small: 70 – 90 mm; Med: 85 – 105 mm; Large: 100 – 120 mm; X-Large: 110-130 mm | Within limits of the standard | |
| Finger thickness | 0.10-0.19 mm | Within limits of the standard | |
| Palm thickness | 0.10-0.16 mm | Within limits of the standard | |
| Cuff thickness | 0.10-0.13 mm | Within limits of the standard | |
| Physical Properties | ASTM D 6319 | AQL 4.0; Before aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%; After aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements (met the requirements for tensile strength before and after aging; also met the requirement for elongation before and after aging) |
| Freedom from Pinholes | ASTM D 6319, ASTM D 5151 | AQL 2.5%, No leakage | Meets requirements (Testing shows it meets the 2.5% AQL requirement in the standards for leakage) |
| Powder Free | ASTM D 6124, ASTM D 6319 | < 2 mg / glove | Meets requirements (Residual powder on the subject device is an average of 0.4 mg/glove within the powder-free limit) |
| Test for Irritation | ISO 10993, Part 10 | Primary Irritation Index ≤ 2.0 | Under the conditions of the study, the device is not an irritant (nonirritating in a 204 subject study) |
| Test for Systemic Toxicity | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals | No evidence of systemic toxicity (considered non-toxic) |
| Test for Skin Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the conditions of the study, the device is not a sensitizer (showed no clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects in a 204 subject study) |
| Resistance to Permeation by Chemotherapy Drugs and Hazardous Drugs (opioids) | ASTM D6978-05 | No breakthrough for up to 240 minutes for the listed chemotherapy drugs and hazardous drugs. For Carmustine and Thiotepa, breakthrough detected in less than 60 minutes. | Chemotherapy Drugs: NO breakthrough detected up to 240 minutes for Azacitidine, Bendamustine HCl, Bleomycin Sulfate, Bortezomib, Busulfan, Capecitabine, Carboplatin, Carlzomib, Cetuximab, Chloroquine, Cisplatin, Cladribine, Cyclophosphamide, Cyclosporin A, Cytarabine (Cytosine), Cytovene (Ganciclovir), Dacarbazine (DTIC), Dactinomycin, Daunorubicin HCl, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl (Ellence), Etoposide (Toposar), Fludarabine, 5-Fluorouracil, Fulvestrant, Gemcitabine, Idarubicin, Ifosfamide, Irinotecan HCl, Leuprolide Acetate Salt, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone, Oxaliplatin, Paclitaxel, Pemetrexed, Raltitrexed, Retrovir, Rituximab, Temsirolimus, Topotecan HCl, Triclosan, Trisenox, Vinblastine Sulfate, Vincristine, Vinorelbine, Zoledronic Acid.Breakthrough detected in less than 60 minutes: Carmustine (0.3 minutes), Thiotepa (30.9 minutes).Hazardous Drugs (opioids): NO breakthrough detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Clinical Test (Modified DRAIZE-95 Test for Low Dermatitis Potential):
- Sample Size: 204 subjects.
- Data Provenance: Not explicitly stated, but implies a prospective study involving normal healthy human volunteers due to the nature of the Draize test. Country of origin is not mentioned.
-
Non-Clinical Tests (Mechanical Properties, Permeation, Biocompatibility): The document does not specify exact sample sizes for each non-clinical test (e.g., number of gloves tested for permeation, pinholes, or physical properties). These are typically laboratory-based tests following standard protocols. Data provenance related to country of origin is not provided, but the tests refer to international standards (ASTM, ISO).
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 section is not applicable as the document describes a medical device (exam gloves) for which "ground truth" as defined for AI/diagnostic studies (e.g., expert consensus on image interpretation) is not relevant. The performance is assessed against established physical, chemical, and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers/experts to establish a definitive diagnosis or assessment, which is not the case here.
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
This is not applicable. The device is an exam glove and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an exam glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests conducted, the "ground truth" is defined by:
- Established industry standards and regulatory limits (e.g., ASTM D6319 for physical properties, ASTM D5151 for pinholes, ASTM D6124 for powder, ASTM D6978-05 for drug permeation, ISO 10993 for biocompatibility).
- Observed physical and chemical properties of the gloves (e.g., measured dimensions, tensile strength, elongation, residual powder, breakthrough time for drugs).
- Clinical observation of human subjects for irritation and sensitization (for the dermatitis potential test).
8. The sample size for the training set
This is not applicable. The document describes the testing of a manufactured physical device (gloves), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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