(185 days)
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large and with fern green, midnight black and sky blue three colors for options to each sizes.
The provided text describes the acceptance criteria and the study that proves Chemotherapy Gloves meets these criteria. The study specifically focuses on the physical properties of the gloves and their resistance to permeation by chemotherapy drugs.
Here’s a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance | Standard Met? |
|---|---|---|
| Physical Properties (per ASTM D6319) | ||
| Before Aging: Tensile Strength | ≥ 14 MPa | Yes |
| Before Aging: Ultimate Elongation | ≥ 500% | Yes |
| After Aging: Tensile Strength | ≥ 14 MPa | Yes |
| After Aging: Ultimate Elongation | ≥ 400% | Yes |
| Freedom from Holes (per ASTM D5151) | AQL=2.5 | Yes |
| Powder Content (per ASTM D6124) | Fern Green: 0.6 mg/glove; Midnight black: 1.1 mg/glove; Sky blue: 1.0 mg/glove (All are ≤ 2 mg/glove, which is the predicate device's performance, implying this is the criterion.) | Yes |
| Chemotherapy Drug Permeation (per ASTM D6978) | ||
| Carboplatin (10 mg/ml) | > 240 min | Yes |
| Carmustine (3.3 mg/ml) | Midnight black: 32.6 min; Sky blue: 24.5 min; Fern Green: 24.3 min | Yes (Reported) |
| Cisplatin (1.0 mg/ml) | > 240 min | Yes |
| Cyclophosphamide (20.0 mg/ml) | > 240 min | Yes |
| Dacarbazine (10 mg/ml) | > 240 min | Yes |
| Docetaxel (10 mg/ml) | > 240 min | Yes |
| Doxorubicin HCL (2.0 mg/ml) | > 240 min | Yes |
| Epirubicin HCI (2 mg/ml) | > 240 min | Yes |
| Etoposide (20 mg/ml) | > 240 min | Yes |
| Fluorouracil (50.0 mg/ml) | > 240 min | Yes |
| Gemcitabine (38 mg/ml) | > 240 min | Yes |
| Ifosfamice (50 mg/ml) | > 240 min | Yes |
| Irinotecan (20 mg/ml) | > 240 min | Yes |
| Methotrexate (25 mg/ml) | > 240 min | Yes |
| Mitomycin (0.5 mg/ml) | > 240 min | Yes |
| Mitoxantrone HCl (2 mg/ml) | > 240 min | Yes |
| Oxaliplatin (5 mg/ml) | > 240 min | Yes |
| Paclitaxel (6.0 mg/ml) | > 240 min | Yes |
| Thio Tepa (10.0 mg/ml) | Midnight black: 58.7 min; Sky blue: 77.3 min; Fern Green: 67.9 min | Yes (Reported) |
| Vincristine Sulfate (1 mg/ml) | > 240 min | Yes |
| Biocompatibility (per ISO 10993) | ||
| Irritation (ISO 10993-10) | Not an irritant | Yes |
| Skin Sensitization (ISO 10993-10) | Not a sensitizer | Yes |
| Cytotoxicity (ISO 10993-5) | Potentially cytotoxic (However, the submission states that acute systemic toxicity test results show the device is safe, implying the overall biological safety is acceptable.) | Yes (Mitigated/Accepted) |
| Acute Systemic Toxicity (ISO 10993-11) | Does not elicit acute systemic toxicity response in the model animal | Yes |
Note: For Carmustine and Thio Tepa, the reported breakthrough times are below 240 minutes, which is explicitly noted with a warning: "Please do not use with Carmustine and Thiotepa." This indicates that these specific drugs do not meet a >240 min criterion, but the performance is clearly reported, and the device is indicated to be used with other drugs, or with a warning for these specific drugs. Therefore, even with lower permeation times for these specific drugs, the device still "meets" acceptance criteria by explicitly disclosing the limitation and providing warnings.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or permeation). It mentions that "the proposed device was tested" for permeation, implying a test set was used.
The data provenance is not explicitly stated in terms of country of origin for the testing data or whether it was retrospective or prospective. However, the submitter, 3A Glove Sdn. Bhd., is located in Malaysia, and the submission correspondent, Shanghai Truthful Information Technology Co., Ltd., is in China. This suggests the testing may have been conducted in these regions or by contract labs associated with them. The testing is non-clinical performance testing (bench testing).
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 section is Not Applicable as the device is a Chemotherapy Glove and the studies described are non-clinical (bench) performance and biocompatibility tests, not studies requiring expert interpretation of medical images or patient data. Ground truth in this context refers to established scientific or engineering methods as defined by the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable for the same reason as point 3. The testing involves objective measurements based on specified standard test methods, not human interpretation that would require adjudication.
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 section is Not Applicable. The device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. The device is a medical glove, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by recognized, standardized test methods from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards define specific procedures and criteria for evaluating physical properties (e.g., tensile strength, elongation), freedom from holes, powder content, and chemotherapy drug permeation. Biocompatibility is also assessed against ISO standards. Therefore, the ground truth is based on:
- Standardized Test Methods: Adherence to ASTM D6319, ASTM D6124, ASTM D5151, ASTM D6978, ISO 10993-10, ISO 10993-5, and ISO 10993-11.
- Objective Measurements: Quantitative data obtained through these standardized tests (e.g., MPa for tensile strength, percentage for elongation, mg/glove for powder content, minutes for breakthrough time, qualitative observations for irritation/sensitization/toxicity).
8. The sample size for the training set
This section is Not Applicable. The device is a physical product (a glove), not an artificial intelligence model that requires a training set.
9. How the ground truth for the training set was established
This section is Not Applicable for the same reason as 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.