(85 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.
This document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile, with Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim. The submission seeks to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-11; ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-11; ASTM D 6319-10 | Meets |
| Low Dermatitis Potential (Biocompatibility) | Modified Draize-95 Test (as per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999") | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. Results of the human repeat insult patch test (HRIPT) on 200 subjects were negative, indicating no potential for inducing dermal irritation or sensitization in the general user population. |
| Dermal Sensitization (Biocompatibility) | ISO 10993-10:2010 | Not a contact skin sensitizer |
| Primary Skin Irritation Test (Biocompatibility) | 16 CFR Part 1500.41 | Not a primary skin irritant |
| Chemotherapy Drugs Permeation Test | ASTM D6978-05 | Dacarbazine (DTIC) (10.0 mg/ml): > 240 minutes |
| Carmustine (BCNU) (3.3 mg/ml): 15.3 minutes | ||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml): > 240 minutes | ||
| Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes | ||
| Fluorouracil (50.0 mg/ml): > 240 minutes | ||
| Cisplatin (1.0 mg/ml): > 240 minutes | ||
| Etoposide (20.0 mg/ml): > 240 minutes | ||
| Paclitaxel (Taxol) (6.0 mg/ml): > 240 minutes | ||
| Thiotepa (10.0 mg/ml): 195.8 minutes |
2. Sample size used for the test set and the data provenance
- Low Dermatitis Potential (Modified Draize-95 Test):
- Sample Size: A total of 200 human subjects.
- Data Provenance: Prospective, clinical study. The document states, "The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested... The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage..."
- Country of Origin: Not explicitly stated, though the submitter is based in Malaysia. The study aimed to reflect "the general user population in the US."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the Modified Draize-95 Test or the Chemotherapy Drugs Permeation Test. These tests are standardized laboratory and human subject tests, respectively, where the "ground truth" is determined by the specific criteria and readings of the test methods rather than expert consensus on subjective findings.
4. Adjudication method for the test set
The document does not describe an adjudication method for the tests performed. For the human subject testing (Modified Draize-95), the results were simply "all negative," indicating no ambiguous findings requiring adjudication. For the other performance tests (e.g., dimensions, physical properties, pinholes, powder residue, chemotherapy permeation), the results are quantitative or pass/fail against established standards.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical glove, and the nature of its evaluation does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used
- For physical properties, pinholes, and powder free residue: Ground truth was established by adherence to recognized ASTM (American Society for Testing and Materials) standards (ASTM D6319-10, ASTM D5151-11, ASTM D6124-11), which define objective test methods and acceptance criteria.
- For biocompatibility (dermal sensitization and primary skin irritation): Ground truth was established by adherence to ISO 10993-10:2010 and 16 CFR Part 1500.41, which are standardized testing protocols for biological evaluation of medical devices.
- For Low Dermatitis Potential: Ground truth was established through a human clinical study (Modified Draize-95 Test) observing the absence of allergic or irritant reactions in human subjects.
- For Chemotherapy Drugs Permeation Test: Ground truth was established by adherence to the ASTM D6978-05 standard, which outlines specific methods for measuring drug permeation through protective materials.
8. The sample size for the training set
This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.
§ 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.