(143 days)
The Nitrile Powder Free Examination Gloves (White) Tested for Use with Chemotherapy Drugs is a non sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Nitrile Powder Free Examination Gloves (VBLU - Violet Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Nitrile Powder Free Examination Gloves (ABLU - Aqua Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Nitrile Powder Free Examination Gloves (VIO - Violet) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs; White, Violet Blue, Aqua Blue and Violet
The provided document describes the "Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs" and its indications for use. The core of the study relates to the gloves' resistance to permeation by various chemotherapy drugs, measured by "Minimum Breakthrough Time."
Here's an analysis based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for gloves used with chemotherapy drugs typically involve demonstrating a minimum breakthrough time for each tested drug, indicating the duration before the drug permeates the glove material. Although the document doesn't explicitly state the acceptance criteria as a single threshold value (e.g., "must be > X minutes"), the implied acceptance is that the reported breakthrough times are sufficient for safe use within a medical context, particularly as a disposable device. The "acceptance" for individual drugs is simply the reported minimum breakthrough time, as this is the performance metric being demonstrated. The document's repeated phrase "Please note that the following drugs have extremely low permeation times..." for some drugs with shorter breakthrough times suggests that while these times are reported, they might be considered low for robust protection.
| Chemotherapy Drug (Concentration) | Minimum Breakthrough Time (Minutes) - White Gloves (Reported Performance) | Minimum Breakthrough Time (Minutes) - Violet Blue Gloves (Reported Performance) | Minimum Breakthrough Time (Minutes) - Aqua Blue Gloves (Reported Performance) | Minimum Breakthrough Time (Minutes) - Violet Gloves (Reported Performance) |
|---|---|---|---|---|
| 1. Carmustine (3.3 mg/ml) | 30.2 | 30.3 | 30.4 | 0.6 |
| 2. Cisplatin (1.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 4. Dacarbazine (10.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 5. Doxorubixin Hydrochloride (2.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 6. Etoposide (Toposar) (20.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 7. Fluorouracil (50.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 8. Methotrexate (25.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 9. Mitomycin C (0.5 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 10. Paclitaxel (6.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
| 11. Thiotepa (10.0 mg/ml) | > 240 | > 240 | 15.6 | 46.7 |
| 12. Vincristine Sulfate (1.0 mg/ml) | > 240 | > 240 | > 240 | > 240 |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (number of gloves or tests per drug) used for determining the breakthrough times. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission, the data would typically be derived from prospective testing conducted to support the submission.
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 study. The ground truth (minimum breakthrough time) is established through standardized laboratory testing for chemical permeation, not through expert consensus or interpretation of medical images.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., image reading). This study involves objective laboratory measurements.
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. This is a study on the material properties of gloves, not an AI-assisted diagnostic device or one involving human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This study does not involve an algorithm.
7. The type of ground truth used
The ground truth used is objective laboratory measurements of chemical permeation, specifically "Minimum Breakthrough Time," determined through a standardized test method (likely ASTM F739 or similar). This is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI-based study. It is a material testing study.
9. How the ground truth for the training set was established
This is not applicable as there is no training set. The ground truth for the performance claim (breakthrough time) is established directly through chemical permeation testing in a laboratory setting.
§ 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.