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510(k) Data Aggregation
(202 days)
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Bleomycin Sulfate (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin HCl (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Epirubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (38.0 mg/ml) Idarubicin HCl (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Rituximab (10.0 mg/ml) Trisenox (1.0 mg/ml) Vincristine Sulfate (1.0 mg/ml)
The tested Opioid is: Fentanyl Citrate Injection (100 mcg/2 mL) Permeation: no breakthrough up to 240 minutes
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 26.3 minutes Thiotepa (10.0 mg/ml) : 49.1 minutes Warning: Not for Use with: Carmustine, Thiotepa
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). The powder-free gloves are made from Nitrile (NBR) latex and are black in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only.
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) include glove sizes: X-Small, Medium, Large, X-Large and XX-Large.
The provided text describes the acceptance criteria and the results of a study for the "Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)".
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method (Characteristic) | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Physical Properties (ASTM D6319-19) | ||
| Length | 220mm minimum for size XS and S; 230mm minimum for size M, L, XL and XXL | Pass |
| Width | XS: 70 ± 10 mm; S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm; XXL: 130 ± 10 mm | Pass |
| Thickness (Palm & Finger) | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Pass |
| Tensile Strength (Before Ageing) | 14MPa min for all sizes | Pass |
| Tensile Strength (After Ageing) | 14MPa min for all sizes | Pass |
| Ultimate Elongation (Before Ageing) | 500% min for all sizes | Pass |
| Ultimate Elongation (After Ageing) | 400% min for all sizes | Pass |
| Freedom from Holes (ASTM D5151-19) | G-I, AQL 2.5 | Pass |
| Powder Free Residue (ASTM D6124-06) | ≤ 2 mg/glove | Pass |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | ||
| Bleomycin Sulfate (15 mg/ml) | >240 Minutes | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes |
| Carmustine (3.3 mg/ml) | 33.8 Minutes (Predicate) | 26.3 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes |
| Mechlorethamine HCl (1 mg/ml) | >240 Minutes | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes |
| Mitoxantrone HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes |
| Thiotepa (10 mg/ml) | 128.1 Minutes (Predicate) | 49.1 Minutes (Subject Device - Note: This value is lower than the predicate's reported value, but both are below 240 mins and thus subject to warning. The specific acceptance criteria for "low permeation" drugs is that they are identified and warned against.) |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes |
| Resistance to Permeation by Opioid Drugs (ASTM D6978-05) | ||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 Minutes | >240 Minutes |
| Biocompatibility (ISO 10993-23: Irritation) | Under the condition of study, not an irritant | Under the conditions of the study, the test article met the requirements of the test. |
| Biocompatibility (ISO 10993-10: Dermal Sensitization) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, the test article was not considered a sensitizer. |
| Biocompatibility (ISO 10993-11: Acute Systemic Toxicity) | Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern | Under the conditions of study, there was no mortality or evidence of acute systemic toxicity. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Bench Data" and "Biocompatibility Data" for the non-clinical tests. For these types of tests, specific sample sizes beyond what's typically required by the ASTM or ISO standards are not detailed in this summary. The data provenance is not specified, but these are standard laboratory tests. It is implied these are prospective tests conducted on the subject device.
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 (N/A). The device is a medical glove, and the evaluation relies on established standardized physical, chemical permeation, and biocompatibility tests, not subjective expert assessment of images or clinical outcomes that would require ground truth establishment by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments (e.g., in medical image interpretation). The tests performed are objective, standardized laboratory tests.
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 section is Not Applicable (N/A). This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the gloves is established by objective measurements against the specified ASTM and ISO standards. For instance:
- Physical properties (length, width, thickness, tensile strength, elongation) are measured directly.
- Freedom from holes is determined by leakage tests per ASTM D5151-19.
- Powder residue is measured per ASTM D6124-06.
- Resistance to permeation by chemotherapy and opioid drugs is determined by measuring breakthrough time according to ASTM D6978-05.
- Biocompatibility is assessed through standardized biological tests (irritation, sensitization, systemic toxicity) as per ISO 10993 series.
8. The sample size for the training set
This section is Not Applicable (N/A). The device is a physical product (medical glove) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
This section is Not Applicable (N/A), as it refers to a training set for machine learning, which is irrelevant for this medical device.
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