(155 days)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs." This is a Class I medical device, and the testing focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. It is crucial to note that this document pertains to a physical medical device (gloves) and not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI/SaMD specific aspects like expert data labeling, MRMC studies, training set data, etc., are not applicable to this submission. The information provided aligns with typical performance testing for physical devices.
Here's the breakdown of the acceptance criteria and reported performance, tailored to the available information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All size ≥230mm |
| ASTM D6319-19 | Palm Width | XS: 70 ± 10mm | |
| S: 80 ± 10mm | |||
| M: 95 ± 10mm | |||
| L: 110 ± 10mm | |||
| XL: 120 ± 10mm | XS: 77-78mm | ||
| S: 86-88 mm | |||
| M: 96-98mm | |||
| L: 108-110 mm | |||
| XL: 116-117 mm | |||
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | ≥0.05mm | ||
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | ≥500% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | ≥400% |
| ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| ASTM D6124-06 (2017) | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use with Chemotherapy Drugs (Minimum BDT) | No explicit numerical acceptance criteria for each drug are listed as "acceptance criteria" in the table. The table provides the reported values for the device. The "Acceptance Criteria" column for this test indicates "/", implying that the objective is to report the measured breakthrough times. Note: For Carmustine (BCNU) and Thio Tepa, the document explicitly states a warning due to "extremely low permeation times." | Bleomycin (15.0mg/ml): >240 |
| Bortezomib (Velcade) 1mg/ml: >240 | |||
| Busulfan (6.0mg/ml): >240 | |||
| Carboplatin, (10.0mg/ml): >240 | |||
| Carmustine(BCNU) (3.3 mg/ml): 7.0 minutes | |||
| Chloroquine, (50.0mg/ml): >240 | |||
| Cisplatin (1mg/ml): >240 | |||
| Cyclophosphamide (Cytoxan) (20mg/ml): >240 | |||
| Cyclosporin, (100.0mg/ml): >240 | |||
| Cytarabine, (100.0mg/ml): >240 | |||
| Dacarbazine (10mg/ml): >240 | |||
| Daunorubicin, HCL (5.0mg/ml): >240 | |||
| Docetaxel, (10.0mg/ml): >240 | |||
| Doxorubicin HCL (2mg/ml): >240 | |||
| Epirubicin HCL (Ellence), (2.0mg/ml): >240 | |||
| Etoposide (20mg/ml): >240 | |||
| Fludarabine, (25.0mg/ml): >240 | |||
| Fluorouracil (50mg/ml): >240 | |||
| Gemcitabine (38.0mg/ml): >240 | |||
| Idarubicin HCL (1.0mg/ml): >240 | |||
| Ifosfamide, (50.0mg/ml): >240 | |||
| Irinotecan, (20.0mg/ml): >240 | |||
| Mechlorethamine HCI, (1.0mg/ml): >240 | |||
| Melphalan, (5.0mg/ml): >240 | |||
| Methotrexate (25mg/ml): >240 | |||
| Mitomycin C, (0.5mg/ml): >240 | |||
| Mitoxantrone, (2.0mg/ml): >240 | |||
| Oxaliplatin, (5.0mg/ml): >240 | |||
| Paclitaxel (Taxol) (6mg/ml): >240 | |||
| Paraplatin, (10.0mg/ml): >240 | |||
| Retrovir, (10.0mg/ml): >240 | |||
| Rituximab, (10.0mg/ml): >240 | |||
| Thio Tepa (10mg/ml): 23.0 minutes | |||
| Topotecan HCL, (1.0mg/ml): >240 | |||
| Trisonex, (1.0mg/ml): >240 | |||
| Vincristine, (1.0mg/ml): >240 |
Regarding the AI/SaMD specific questions, the following points are not applicable as this document describes performance testing for a physical medical glove.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample sizes for each physical test (e.g., how many gloves were tested for tensile strength, or how many samples for biocompatibility). Standard test methods (ASTM, ISO) typically define minimum sample sizes. The data provenance is implied to be from testing labs in relation to the manufacturer (Shanxi Hongjin Plastic Technology Co., Ltd. in China) and their US representative. This is a prospective testing of the manufactured product.
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)
- Not applicable. Ground truth for physical device performance is established by standardized laboratory testing methods (ASTM, ISO) rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for human-in-the-loop assessments or expert consensus in image interpretation, not for physical material testing.
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/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/SaMD. The "standalone" performance here refers to the physical properties of the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The 'ground truth' for this device is based on objective measurements derived from standardized testing protocols (ASTM and ISO standards) measuring physical properties (like length, thickness, tensile strength, freedom from holes, powder content) and chemical resistance (breakthrough time for chemotherapy drugs), as well as biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set
- Not applicable. This is not an AI/SaMD, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for physical device testing, there is no ground truth establishment method for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international (ISO) and national (ASTM) standards. These tests assess the physical, chemical, and biological properties of the nitrile examination gloves.
The "Non-Clinical Performance Data" section (Page 9 of the document) explicitly lists the test methods used, their purpose, the acceptance criteria, and the results, confirming that the proposed device complies with these standards. For example, ASTM D6319-19 was used for dimensions and tensile properties, ASTM D5151-19 for freedom from holes, ASTM D6124-06 for powder content, and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Biocompatibility was assessed using ISO 10993 series standards (Parts 5, 10, and 11) for cytotoxicity, irritation, sensitization, and systemic toxicity.
The conclusion states, "The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device." This indicates that the results met the established benchmarks (which are often derived from the requirements of the standards themselves or comparison to a predicate 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.