(12 days)
The glove 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 and Fentanyl Citrate using ASTM D6978-05(2019)
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width (XS, S, M, L, XL, XXL) | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness (Finger, Palm) | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Tensile Strength, Elongation) | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to the table below for specific drug BDTs | Pass (Based on individual BDTs) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells. (Note: Cytotoxicity concern was addressed by acute systematic toxicity testing to still meet acceptance) |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity |
Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes (Acceptance Criteria) | Reported Device Performance (BDT in Minutes) |
|---|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | Explicit criteria not listed, but compared to predicate and results are 11.2 min, with a caution against use. | 11.2 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 (Implicitly, as predicate is >240 and proposed is same) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 (Implicitly) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 (Implicitly) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 (Implicitly) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 (Implicitly) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 (Implicitly) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 (Implicitly) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 (Implicitly) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | Explicit criteria not listed, but compared to predicate and results are 29.4 min, with a caution against use. | 29.4 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 (Implicitly) | >240 |
Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.
- Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
- Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.
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 "ground truth" for examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.
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. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance of these gloves is defined by:
- Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
- Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
- Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.
8. The sample size for the training set
This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.