(76 days)
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs and Fentary) 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes.
The Powder Free Nitrile Examination Gloves, White, Test For Use With Chemotherapy Drugs and Fentanyl 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The Powder Free Nittile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentary 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
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This document is a 510(k) premarket notification for disposable examination gloves, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI device, sample sizes for training/test sets, expert qualifications, etc.) is not applicable here.
However, I can extract the performance data of the gloves with respect to chemotherapy drug permeation, which serves as a kind of "acceptance criteria" and the "study" that proves the device meets it for this particular medical device.
1. A table of acceptance criteria and the reported device performance:
The acceptance criterion for these gloves is their resistance to permeation by specific chemotherapy drugs and Fentanyl. The "performance" is the measured Breakthrough Detection Time (in minutes) when tested according to ASTM D6978-05 (2019). A higher breakthrough time indicates better resistance.
Powder Free Nitrile Examination Gloves (Blue)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 21.1 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 43.3 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Powder Free Nitrile Examination Gloves (White)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 11.9 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 33.0 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Powder Free Nitrile Examination Gloves (Black)
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Conceptual) | Reported Breakthrough Detection Time in Minutes |
|---|---|---|---|
| Carmustine | 3.3 mg/ml (3,300 ppm) | (Higher is better) | 11.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | (Higher is better) | >240 |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | (Higher is better) | >240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | (Higher is better) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | (Higher is better) | >240 |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | (Higher is better) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | (Higher is better) | >240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | (Higher is better) | >240 |
| Thio Tepa | 10.0 mg/ml (10,000 ppm) | (Higher is better) | 28.7 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | (Higher is better) | >240 |
| Fentanyl Citrate Injection | 100mcg/2ml | (Higher is better) | >240 |
Note: The document explicitly states "Warning: Don't use with either Carmustine or Thiotepa" for all glove types, indicating that for these specific drugs, the breakthrough times (e.g., 11.3 - 43.3 minutes) are considered insufficient for safe use. This itself serves as an implicit "acceptance criterion" that for these two drugs no amount of permeation time would be considered acceptable for use. For the other drugs, ">240 minutes" is the reported performance, implying that the gloves withstand permeation for at least 4 hours, which is likely considered an acceptable duration for many clinical applications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size (number of gloves or tests performed per drug). It simply states that the gloves "were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs". This standard details the testing methodology, which typically involves multiple replicate tests.
- Data Provenance: The testing was done in accordance with an international standard (ASTM D6978-05), suggesting a controlled laboratory environment. The manufacturer is Zibo Lanhua Medical Packaging Material Co., Ltd, based in Zibo, Shandong, China. The testing itself would be prospective in nature, as it's specifically conducted to evaluate the performance of these new glove formulations.
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 question is not applicable to this type of device. The "ground truth" here is objective physical measurement of chemical permeation, not subjective expert assessment of medical images or patient data. The "experts" involved would be laboratory technicians or chemists experienced in conducting ASTM D6978-05, not medical specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple experts might disagree. Chemical permeation testing is a standardized, objective measurement.
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
Not applicable. This is not an AI/ML device, nor does it involve human readers or comparative effectiveness studies in the context of diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is objective, laboratory-measured chemical permeation data, obtained using a standardized testing method (ASTM D6978-05). This is a direct physical measurement.
8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.