(74 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
The provided document is a 510(k) summary for Zibo Yuechuan Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It is intended for regulatory approval of a medical device, not an AI/ML powered device. Therefore, much of the requested information (like AI-specific metrics, expert ground truth, training sets, etc.) is not applicable here.
However, I can extract the relevant "acceptance criteria" (which in this context are performance standards for gloves) and how the device meets them based on the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | Meets all requirements (Inspection Level S-2, AQL 2.5) |
| FDA 1000 ml Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Powder-Free Claim (powder content) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Biocompatibility requirements | Meets biocompatibility requirements (implied by skin irritation/sensitization tests) |
| Labeling Claims | Meets labeling claims |
| Applicable 21 CFR references | Conforms fully |
Study Details (as applicable for a non-AI medical device):
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Sample size used for the test set and the data provenance:
- Pinhole Testing (FDA 1000 ml Water Fill Test): AQL (Acceptable Quality Limit) 2.5, Inspection Level I. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards, which refer to statistical sampling plans.
- Physical and Dimensions Testing: AQL 2.5, Inspection Level S-2. Similar to pinhole testing, the exact sample size is determined by the standard and specified AQL.
- Primary Skin Irritation and Skin Sensitization Testing: The document states "conducted with results showing no primary skin irritant or sensitization reactions," but does not specify the sample size of subjects or the methodology of these biological tests beyond the positive outcome.
- Data Provenance: Not specified, but generally, such tests are conducted in certified laboratories. The manufacturing origin is China.
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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. For this type of medical device (gloves), "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert interpretation of data.
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Adjudication method for the test set:
- Not applicable. Performance is measured against quantitative and qualitative standards, not through adjudication of expert opinions.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a study type for diagnostic algorithms or imaging, not for patient examination gloves.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
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The type of ground truth used:
- Performance against established engineering and biological standards (e.g., ASTM D5250-06 for physical properties, FDA 1000ml water fill for barrier integrity, and standard biocompatibility tests for skin reactions).
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The sample size for the training set:
- Not applicable, as this is not an AI/ML device. The "training" for such a product would be the manufacturing process control and quality system.
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How the ground truth for the training set was established:
- Not applicable. The manufacturing process and quality checks ensure the product meets the specifications, guided by the aforementioned standards.
§ 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.