Search Results
Found 1 results
510(k) Data Aggregation
(97 days)
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
The subject device is a dark blue colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves.
The provided document is a 510(k) summary for medical examination gloves and does not relate to AI/ML powered medical devices. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training set ground truth was established) are not applicable and are not present in this type of submission.
However, I can extract the acceptance criteria and performance data for the device itself (the gloves).
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Chemotherapy Drugs Permeation Resistance | ASTM D6978-05 | No breakthrough for specific drugs up to 240 minutes. | No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCI (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Methotrexate (25 mg/ml), Mitomycin C (0.5 mg/ml), Mitoxantrone HCI (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml), Fentanyl Citrate Injection (100 mcg/2 mL), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution. Breakthrough detected in less than 90 minutes for: ThioTEPA (10 mg/ml) at 88.6 minutes. Breakthrough detected in less than 60 minutes for: Carmustine (3.3 mg/ml) at 55.2 minutes. Warning: Do not use with Carmustine or ThioTEPA. |
| Freedom from Pinholes (Leakage) | ASTM D5151-06, ASTM D6319 | 2.5% AQL requirement for leakage. No leakage. | Meets the 2.5% AQL requirement for leakage. Meets the acceptance criteria. |
| Residual Powder | ASTM D6124-06, ASTM D6319 | < 2 mg maximum powder per glove. | Average of 0.4 mg/glove, within the powder-free limit. Meets acceptance criteria. |
| Physical Dimensions (Length) | ASTM D6319 | PureZero MARIN Nitrile: 235 - 250 mm. PureZero MARIN-XTRA Nitrile: 295 - 325 mm. | Meets requirements. |
| Physical Dimensions (Palm Width) | ASTM D6319 | XSmall: 60 – 80 mm; Small: 70 - 90 mm; Med: 85–105 mm; Large: 100 - 120 mm; X-Large: 110-130 mm. | Meets requirements. |
| Physical Dimensions (Thickness - Finger, Palm, Cuff) | ASTM D6319 | Finger: 0.10-0.19 mm; Palm: 0.10-0.16 mm; Cuff: 0.10-0.13 mm. | Meets requirements. |
| Physical Properties (Tensile Strength & Ultimate Elongation - Before Aging) | ASTM D6319 | Tensile Strength: ≥14 MPa; Ultimate Elongation: ≥500%. | Meets requirements. |
| Physical Properties (Tensile Strength & Ultimate Elongation - After Aging) | ASTM D6319 | Tensile Strength: ≥14 MPa; Ultimate Elongation: ≥400%. | Meets requirements. |
| Biocompatibility - Indirect Irritation Study | ISO 10993, Part 10 | Primary Irritation Index ≤2.0. | Test article was considered nonirritating. Meets acceptance criteria. |
| Biocompatibility - Systemic Toxicity Study | ISO 10993, Part 11 | No animals treated with test extracts exhibit greater reaction than control animals. | No evidence of systemic toxicity. Test article considered non-toxic. Meets acceptance criteria. |
| Biocompatibility - Dermal Sensitization | ISO 10993, Part 10 | Grade < 1. | Under the conditions of the study, the device is not a sensitizer. Meets acceptance criteria. |
2. Sample sized used for the test set and the data provenance:
The document refers to various ASTM and ISO standards for testing. These standards define the sample sizes and testing methodologies. For example, ASTM D5151-06 (Detection of Holes) typically involves a water leak test on a statistically significant sample based on AQL (Acceptable Quality Level). ASTM D6978-05 (Chemotherapy Permeation) involves testing multiple gloves for each drug. The specific sample sizes for each test are not explicitly stated in the 510(k) summary, but adherence to these standards implies standard sampling appropriate for the tests.
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted according to relevant international standards. This is a pre-market submission, so it represents performance characteristics of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical and chemical property tests, not expert-opinion-based assessments like image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These are objective laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
7. The type of ground truth used:
For most tests (e.g., physical dimensions, tensile strength, powder content, pinholes), the "ground truth" is directly measured by calibrated instruments and procedures as defined by the referenced ASTM and ISO standards.
For chemotherapy drug permeation, the "ground truth" is the empirically observed breakthrough time using analytical methods.
For biocompatibility, the "ground truth" is established through standardized biological evaluations using animal models as per ISO 10993 guidelines, assessing for specific adverse reactions (irritation, toxicity, sensitization).
8. The sample size for the training set: Not applicable (no AI/ML model being trained).
9. How the ground truth for the training set was established: Not applicable (no AI/ML model being trained).
Ask a specific question about this device
Page 1 of 1