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510(k) Data Aggregation
(346 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).
The document describes the acceptance criteria and performance of "Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Biocompatibility | |||
| ISO 10993-10: Irritation | Irritation Testing | Pass/Fail | Pass (Not a skin irritant) |
| ISO 10993-10: Sensitization | Sensitization Testing | Pass/Fail | Pass (Not a skin sensitizer) |
| ISO 10993-5: Cytotoxicity | Cytotoxicity Testing | Pass/Fail | Fail (Exhibits severe cytotoxicity reactivity) - Note: This is acknowledged and addressed in the Summary of Non-Clinical Testing. |
| ISO 10993-11: Systemic Toxicity | Systemic Toxicity Testing | Pass/Fail | Pass (Not toxic) |
| Permeation Testing (ASTM D6978-05(2019)) | Assessment of resistance to permeation by chemotherapy drugs and Fentanyl | Minimum breakthrough times | See detailed table below for each chemical. The general criterion is to report breakthrough time. |
Detailed Permeation Testing Results:
| Chemotherapy Drug and Concentration | Reported Breakthrough Detection Time (Minutes) |
|---|---|
| Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) | > 240 min |
| Carmustine (BCNU), 3.3 mg/ml (3,300ppm) | 46.6 min |
| Chloroquine 50mg/ml (50,000ppm) | > 240 min |
| Cisplatin, 1.0 mg/ml (1,000ppm) | > 240 min |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) | > 240 min |
| Dacarbazine, 10.0mg/ml (10,000ppm) | > 240 min |
| Docetaxel, 10mg/ml (10,000ppm) | > 240 min |
| Doxorubicin HCI, 2.0mg/ml (2,000ppm) | > 240 min |
| Etoposide, 20.0mg/ml (20,000ppm) | > 240 min |
| Fluorouracil, 50.0mg/ml (50,000ppm) | > 240 min |
| Ifosfamide, 50 mg/ml (50,000 ppm) | > 240 min |
| Methotrexate, 25mg/ml (25,000 ppm) | > 240 min |
| Mitomycin C, 0.5 mg/ml (500 ppm) | > 240 min |
| Paclitaxel, 6.0 mg/ml (6,000 ppm) | > 240 min |
| Thiotepa, 10.0mg/ml (10,000ppm) | 64.8 min |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | > 240 min |
| Fentanyl Citrate Injection 100mcg/2ml (50mcg/1ml) | > 240 min |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of gloves tested for each permeation or biocompatibility test. The document refers to compliance with standards like ASTM D6978-05(2019) and ISO 10993, which typically specify sample sizes for such tests.
- Data Provenance: The testing was performed for the submitter, PT. Shamrock Manufacturing Corpora, based in North Sumatera, Indonesia. The tests are "non-clinical tests," implying laboratory-based testing rather than clinical data from human subjects.
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 information is not applicable as the document describes non-clinical testing of a medical device (gloves) for physical properties and chemical resistance. There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation. The ground truth for these tests is defined by the standardized methodologies of ASTM and ISO.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the document describes non-clinical testing of a medical device (gloves). Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant 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 information is not applicable. The device is medical examination gloves, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. The device is medical examination gloves, not an algorithm or software. The tests performed are laboratory-based assessments of material properties and chemical resistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by standardized test methods and material science principles. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards. For permeation, it's the measured breakthrough time according to ASTM D6978-05(2019). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set:
- This information is not applicable. There is no "training set" in the context of device testing for medical gloves. This refers to a dataset used to train AI/machine learning models, which is irrelevant for this device.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #8.
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