(169 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves (Blue), non-sterile.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) | Meets |
| Freedom from Holes | ASTM D 6319-00a(2005) | |
| ASTM D 5151-06 | Meets | |
| Meets AQL 1.5 | ||
| Powder Free Residual | ASTM 6124-06 | Less than 2 mg per glove |
| Biocompatibility: Primary Skin Irritation Test in Rabbits | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.41 & 1500:3(C)(4) | Passes |
| Biocompatibility: Guinea Pig Sensitization Test | ISO 10993-10: 2002(E), Dermal Sensitization Assay-Closed Patch Test | Passes |
Regarding the study proving the device meets the acceptance criteria, the provided document is a 510(k) summary for a medical device (Powder-Free Nitrile Examination Gloves). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI/imaging device. Therefore, many of the requested points below (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this type of submission for examination gloves.
However, based on the information provided, we can infer the following about the testing and evidence:
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. For physical property testing of gloves, sample sizes are typically defined by the specific ASTM standards (e.g., a certain number of gloves per batch for dimension, tensile strength, and freedom from holes testing).
- Data Provenance: Not explicitly stated, but based on the nature of manufacturing and testing for medical devices, it would be retrospective data collected during the production and quality control processes of the manufacturer (THAI HUA HOLDING COMPANY LIMITED). The country of origin of the data would likely be Thailand, where the manufacturer is located, or potentially the location of the testing laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. For physical and biocompatibility testing of gloves, "experts" in the sense of clinician reviewers establishing ground truth for disease detection are not relevant. The "ground truth" is objective measurement against specified standards. Testing would be performed by lab technicians or engineers trained in the relevant ASTM and ISO standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As the "ground truth" relies on objective measurements against standards, an adjudication method for different human interpretations is not needed. Test results either meet the numerical criteria or they don't.
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 device is an examination glove, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used:
- Objective Measurements/Standards: The ground truth for this device's performance is established by the specified ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards, and Consumer Product Safety Commission regulations. For example:
- Dimensions and Physical Properties: Direct measurements of glove size, tensile strength, elongation, etc., compared against the numerical ranges defined in ASTM D 6319-00a(2005).
- Freedom from Holes: Water leak testing as per ASTM D 5151-06, yielding a quantified Acceptable Quality Level (AQL).
- Powder Free Residual: Measurement of residual powder, compared against the limit in ASTM 6124-06.
- Biocompatibility: Results from standardized animal (rabbit, guinea pig) tests for irritation and sensitization, evaluated against established toxicology protocols.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device that requires a "training set." The testing methods are based on established engineering and materials science principles.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See 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.