(140 days)
A patient examination glove is a disposable device 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 chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 28.6 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 38.1 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 28.6 minutes Thiotepa (10.0 mg/ml) 38.1 minutes Warning: Do not use with Carmustine and Thiotepa
Medline Sterile Powder-Free Nitrile Examination Gloves - Blue (Tested for use with Chemotherapy Drugs)
The provided document is a 510(k) premarket notification clearance letter for "Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Tested for Use with Chemotherapy Drugs)". The relevant information regarding acceptance criteria and testing is found in the "Indications for Use" section.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Clause) | Reported Device Performance (Breakthrough Time for Chemotherapy Drugs) |
|---|---|
| ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | Minimum Breakthrough Time |
| Carmustine (BCNU) 3.3 mg/ml: 28.6 minutes | |
| Cisplatin 1.0 mg/ml: >240 minutes | |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 minutes | |
| Dacarbazine (DTIC) 10.0 mg/ml: >240 minutes | |
| Doxorubicin Hydrochloride 2.0 mg/ml: >240 minutes | |
| Etoposide (Toposar) 20.0 mg/ml: >240 minutes | |
| Fluorouracil 50.0 mg/ml: >240 minutes | |
| Methotrexate 25.0 mg/ml: >240 minutes | |
| Mitomycin C 0.5 mg/ml: >240 minutes | |
| Paclitaxel (Taxol) 6.0 mg/ml: >240 minutes | |
| Thiotepa 10.0 mg/ml: 38.1 minutes | |
| Vincristine Sulfate 1.0 mg/ml: >240 minutes |
Note: The document specifies that "These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013)". The acceptance criteria for this standard typically relates to the minimum breakthrough time for a glove when exposed to chemotherapy drugs, indicating the time it takes for the drug to permeate the glove material. While the document reports the breakthrough times, it does not explicitly state the pre-defined "acceptance" threshold for each drug within the context of this specific regulatory submission. However, the reported values demonstrate the performance against the standard.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full 510(k) submission, not in this summary clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing for chemotherapy drug permeation is a physical/chemical test performed in a laboratory setting, not an interpretation-based assessment requiring human experts to establish ground truth.
4. Adjudication method for the test set
This information is not applicable. As stated above, the testing is objective and laboratory-based, not involving human interpretation or adjudication.
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. This is a physical protective barrier device (gloves), not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a physical device, and the testing involves laboratory measurements of its physical properties (permeation resistance), not algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this testing is based on objective laboratory measurements of chemotherapy drug permeation, as defined by the ASTM D6978-05 (Reapproved 2013) standard. This standard specifies the methodology for determining the breakthrough time of medical gloves to chemotherapy drugs.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of testing a physical device like these gloves for chemotherapy drug permeation. This is not an AI/machine learning application.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth established for it in this context.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.