(137 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.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).
The provided text describes the acceptance criteria and the results of various tests conducted for the "Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs)". This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in a clinical context. Therefore, many of the requested elements for an AI/medical device study (like sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, training set sample size, etc.) are not applicable to this type of submission.
However, I can extract the acceptance criteria and reported device performance from the provided biocompatibility and performance testing summaries.
1. Table of acceptance criteria and the reported device performance
Biocompatibility Testing Summary
| Test Standard | Test Standard Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-10 | Primary Skin Irritation | Cutaneous macroscopical examinations are performed after removal of test material. The appearance of each application site and skin reaction observed are scored. | No skin reactions observed. Not a skin irritant. |
| ISO 10993-10 | Dermal Sensitization | Challenge sites are visually assessed for allergic reactions and the intensity of the reaction is scored. | No positive allergic reactions observed. Not a skin sensitizer. |
| ISO 10993-5 | Cytotoxicity | Test articles scoring '0', '1', or '2' are considered 'non-cytotoxic.' Test articles scoring '3' or '4' are considered 'cytotoxic.' | At the neat extraction, the test article is considered cytotoxic. |
| ISO 10993-11 | Acute Systemic Toxicity | Abnormal clinical signs indicative of toxicity during the 72 hours test period are observed and reported. | No signs of toxicity at any of the observation periods were observed. |
Performance Testing Summary
| Test Standard | Test Standard Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-10 | Standard Specification for Nitrile Examination Gloves for Medical Application | Samples shall meet specified physical dimensions in accordance with the standard. | All device dimensions meet the standard. |
| ASTM D6124-06 (Reaffirmation 2011) | Standard Test Method for Residual Powder on Medical Gloves | 240 mins) |
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 specify sample sizes for each test mentioned (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). The tests are performed according to established ASTM and ISO standards, which typically define the required sample sizes for quality control and performance evaluation.
Data provenance is not explicitly stated as "country of origin of data" but refers to tests being conducted according to international standards (ASTM, ISO). These are bench tests, not clinical studies. The data would be considered prospective in the sense that the tests were specifically performed for this submission to evaluate the device.
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 is not applicable as the tests described are laboratory/bench tests, not evaluations requiring expert interpretation of clinical data in the context of ground truth establishment. The "ground truth" here is determined by chemical and physical measurements against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements against defined standards, not requiring human 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
Not applicable. This is a submission for medical gloves, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a submission for medical gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For physical and chemical properties, the "ground truth" is based on objective measurements defined by international standards (ASTM and ISO). For example:
- Physical dimensions are measured against the specifications in ASTM D6319-10.
- Residual powder is measured against a limit in ASTM D6124-06.
- Detection of holes is defined by the absence of leakage in ASTM D5151-06.
- Chemotherapy drug permeation is measured by breakthrough time according to ASTM D6978-05.
- Biocompatibility assessments (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by standardized laboratory protocols with established biological endpoints according to ISO 10993 series.
8. The sample size for the training set
Not applicable. This is a device (medical glove) and not an AI or machine learning algorithm that requires a training set. The device's characteristics are inherent to its manufacturing process and materials.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a medical glove.
§ 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.