(54 days)
Powder Free Nitrile Examination Glove, Violet Color is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Powder Free Nitrile Examination Gloves, Violet Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6913-00a Standard Specification for Nitrile Examination Gloves. They are violet in colour and are powder free.
The provided document is a 510(k) summary for POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR. This submission is for a medical device (examination gloves), not an AI/algorithm-driven device. Therefore, many of the requested elements for AI device evaluation are not applicable.
However, I can extract the information relevant to the acceptance criteria and the "study" (nonclinical tests) performed to demonstrate compliance for this type of device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Performance Demonstrated |
|---|---|
| ASTM D 6913-00a Standard Specification for Nitrile Examination Gloves for Medical Application | Gloves meet all current ASTM Standard Specification requirements for Nitrile Examination Gloves for Medical Application. |
| 21 CFR 800.20 (Quality System Regulation for Medical Devices: General) | Assumed compliance and verified through periodic QS inspections by FDA. |
| Primary skin irritation test (in rabbit) | No irritation. |
| Delayed contact sensitization test (in guinea pig) | No sensitization. |
| USP iodine test for starch | Negative for the presence of starch. |
| Biocompatibility requirements | Meets all. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, etc., per ASTM D 6913-00a). It states "Testing performed per ASTM D 6913-00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig."
- Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the requirements of the referenced ASTM standard and animal testing protocols.
- Data Provenance: Not explicitly stated as "country of origin," but the testing was performed for a Malaysian manufacturer, LATEXX MANUFACTURING SDN. BHD. The tests are non-clinical (laboratory and animal studies). Retrospective or prospective is not applicable in the context provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. "Ground truth" in the context of an AI device usually refers to expert-annotated data. For examination gloves, performance is assessed against established physical, chemical, and biological standards through laboratory and animal testing.
4. Adjudication method for the test set
Not applicable for this type of device. Performance is determined by standardized laboratory measurements and observations in animal models, not by human reader consensus on an "image" or "case."
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 not an AI-driven device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on well-established industry standards and scientific methods:
- Standard Specifications: Adherence to ASTM D 6913-00a for physical and performance characteristics of examination gloves.
- Established Biological Tests: Results from standardized primary skin irritation tests (in rabbits) and delayed contact sensitization tests (in guinea pigs).
- Chemical Tests: Results from the USP iodine test for starch.
8. The sample size for the training set
Not applicable. This is not an AI-driven device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-driven device.
§ 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.