(239 days)
Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
Latex examination gloves - ambidextrous
The provided text is a 510(k) summary for latex examination gloves, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert involvement, and ground truth establishment, are not applicable.
However, I can extract information relevant to the regulatory approval process and performance testing of the latex examination gloves.
Here's a summary tailored to the provided text:
Acceptance Criteria and Study for Latex Examination Gloves
This 510(k) pertains to latex examination gloves, not an AI/ML device. The "acceptance criteria" here refer to the standards the gloves must meet to be considered substantially equivalent to a predicate device. The "study" refers to the testing conducted to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Predicate Device (Safeskin Satin Plus Latex Examination Gloves) | Kandio Healthcare Corporation (Device under review) |
|---|---|---|
| ASTM D 5712 | Same (Implies compliance) | Completed |
| ASTM 3578-91 | Same (Implies compliance) | Completed |
| Glove Material | Latex | Latex |
| Low Protein | ≤ 50 Micrograms (Claim) | ≤ 50 Micrograms (Claim) |
| Intended Use | Examination | Examination |
| Packaging | 100 Pack dispenser | 100 Pack dispenser |
Explanation of Performance: The device ("Marsin" which is likely the manufacturer mentioned as Marcon Rubber Industrial, Incorporated, whose products include SkinGard TPF, AOSSTEX TPF, SensiFree, Essential TPF, and Amerglo TPF) completed testing according to ASTM D 5712 and ASTM 3578-91, matching the "same" performance characteristics as the predicate device (Safeskin Satin Plus Latex Examination Gloves). This implies the device met the requirements of these standards. The protein content claim of "≤ 50 Micrograms" is also stated as "same" as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the provided text. The ASTM standards (D 5712 and 3578-91) would specify the required sample sizes for their respective tests, but these details are not present in this summary.
- Data Provenance: Not explicitly stated. The tests would likely have been conducted by the manufacturer or a certified lab to demonstrate compliance with ASTM standards.
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 this is not an AI/ML device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" here refers to the physical properties of the gloves as measured by standard laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 (two readers agree, third resolves) are used for discrepant interpretations in medical imaging or diagnosis. For physical product testing, the results are typically objectively measured against pre-defined specifications.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for latex examination gloves is established through standardized physical and chemical laboratory testing according to ASTM (American Society for Testing and Materials) standards. This includes properties such as:
- Tensile strength
- Elongation
- Freedom from holes
- Dimensions
- Protein content (for low protein claims)
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML 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.