(213 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical 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 and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff is a non-sterile disposable device intended for medical 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 and Fentanyl Citrate.
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The provided text is a 510(k) premarket notification letter from the FDA regarding two types of examination gloves:
- Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff
The document primarily focuses on the substantial equivalence determination for these gloves and their performance against chemotherapy drugs and fentanyl citrate, as tested per ASTM D6978-05.
Therefore, the concept of "acceptance criteria," "study," or "device performance" in the context of an AI/ML medical device (as implied by the detailed questions about ground truth, MRMC studies, test/training sets, and expert adjudication) is not applicable here. This document is about clearance of physical medical devices (gloves) based on their barrier performance against certain substances, not about an AI/ML algorithm's diagnostic or predictive capabilities.
The "device performance" in this context refers to the breakthrough detection time of various chemotherapy drugs and Fentanyl Citrate through the glove material.
However, to address the prompt as best as possible, I will extract the "acceptance criteria" (which are performance results, not pre-defined criteria from the FDA letter itself, but results proving performance) and the "study" details based on the information provided for the physical gloves.
Acceptance Criteria and Study for Nitrile Examination Gloves (Physical Device)
This document concerns the 510(k) clearance of two types of Nitrile Powder Free Examination Gloves. The "performance" of these devices relates to their ability to act as a barrier against specific chemotherapy drugs and Fentanyl Citrate. The "acceptance criteria" are implicitly met by demonstrating breakthrough times as measured by the specified ASTM standard.
1. Table of Acceptance Criteria (Performance Results) and Reported Device Performance
The acceptance criteria are not explicitly stated as strict cut-offs in the document but are demonstrated performance values for permeation resistance. The "reported device performance" are the measured breakthrough times.
Device: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Reported Performance) |
|---|---|
| Carmustine (3.3 mg/ml) | 2.73 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 22.82 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes (Reported Performance) |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Device: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Reported Performance) |
|---|---|
| Carmustine (3.3 mg/ml) | 30.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 61.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes (Reported Performance) |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Note regarding "Acceptance Criteria": The document doesn't define specific minimum breakthrough times as "acceptance criteria" but presents the measured performance. The implied acceptance is that these values are deemed sufficient for substantial equivalence according to FDA's review for these specific glove types and indicated uses, noting the warnings for Carmustine and Thiotepa.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of gloves or tests performed (sample size) for each chemical. However, the testing was conducted "as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," which would define the required sample size and methodology.
- Data Provenance: Not explicitly stated (e.g., country of origin for the testing lab). The testing is retrospective in nature, as it's a characterization of a manufactured product.
Regarding AI/ML specific questions (not applicable to this physical device):
The following points are typically relevant for AI/ML medical device studies but are not applicable to this document, which describes the clearance of physical examination gloves. There is no AI/ML component mentioned or implied.
- 3. Number of experts used to establish the ground truth... (Not applicable - no image interpretation or diagnostic task)
- 4. Adjudication method... (Not applicable - no human expert ground truth establishment)
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done... (Not applicable - no human readers or AI assistance in a diagnostic context)
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done... (Not applicable - no algorithm)
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) (Not applicable in the AI/ML sense; the "ground truth" here is the measured chemical permeation time by a standardized laboratory method.)
- 8. The sample size for the training set (Not applicable - no training set for an AI/ML model)
- 9. How the ground truth for the training set was established (Not applicable - no training set for an AI/ML model)
§ 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.