(75 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes a 510(k) summary for a medical device: Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove. This is a Class I device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI system or diagnostic tool requiring complex clinical studies.
Therefore, many of the requested categories related to AI performance, multi-reader studies, and detailed ground truth establishment for complex medical imaging or diagnostics are not applicable to this type of device submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements of ASTM standard D-5250-06e1. |
| Pinhole Requirements: | Meets FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level I). |
| Biocompatibility - Primary Skin Irritation: | No primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization: | No sensitization reactions (allergic contact dermatitis). |
| Powder-Free Claim: | Contains no more than 2 mg powder per glove (based on ASTM D-6124-06). |
Study Information
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Sample sizes used for the test set and the data provenance:
- Pinhole Test: Inspection level I, AQL 2.5 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0 (The exact sample size isn't explicitly stated but is determined by these AQL parameters).
- Biocompatibility Tests: The text mentions "testing was conducted" but does not specify sample size or provenance (e.g., human subjects, animal studies, in-vitro).
- Powder Test: The text mentions "at finished inspection" but does not specify a separate sample size for the test.
- Data Provenance: Not explicitly stated, but typically for such product testing, it would be conducted at the manufacturing site or a certified testing laboratory.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for glove performance involves objective physical and chemical measurements governed by established ASTM standards and FDA test methods, not expert interpretation of medical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective pass/fail criteria based on measured values against standards.
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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 a patient examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is based on pre-defined, objective ASTM standards and FDA test methods for physical properties, dimensions, pinhole defects, biocompatibility, and residual powder. These are measurable values against a threshold.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.