(48 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.
Based on the provided text, the device in question is Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This is a Class I medical device, and the submission is a 510(k) for substantial equivalence to a predicate device, not for the approval of a novel AI/ML-driven diagnostic or therapeutic device. Therefore, many of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set") are not applicable to this type of device and study.
Here's the information that is applicable based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM-D-5250-06 (Physical and Dimensions Testing) | Meets all requirements for Physical and Dimensions Testing, Inspection Level S-2, AOL 2.5. |
| FDA 1000 ml. Water Fill Test (Pinhole) | Meets requirements with samplings of AOL 2.5, Inspection Level 1. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Powder Content (for Powder-Free claim) | Meets "powder-free" claim (contains no more than 2 mg powder per glove). |
| Biocompatibility requirements | Meets requirements (as shown by data in Section 7). |
| Applicable 21 CFR references | Conforms fully to applicable 21 CFR references. |
| Labeling Claims | Meets labeling claims. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single number. The document mentions "samplings of AOL 2.5, Inspection Level 1" for the FDA Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are statistical sampling plans based on Acceptable Quality Limits (AQLs) but do not provide a total sample count.
- Data Provenance: Not explicitly stated beyond the manufacturer being in China. The testing was conducted to meet ASTM and FDA standards. The nature of the tests on physical properties of gloves means the "provenance" is largely the manufacturing process and materials.
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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 is established by objective physical and chemical testing against defined standards (ASTM, FDA water fill test, biocompatibility). It does not involve expert consensus in the way a diagnostic image interpretation would.
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Adjudication method for the test set: Not applicable. Performance is determined by objective measurements against established standards, not by human adjudication of qualitative data.
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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 is a medical device for physical protection, not an AI-driven diagnostic or therapeutic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
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The type of ground truth used:
- Objective measurements against established industry standards (ASTM-D-5250-06).
- Regulatory requirements (FDA 1000 ml. Water Fill Test).
- Biocompatibility testing (Primary Skin Irritation, Skin Sensitization).
- Chemical analysis (powder content).
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The "training" for glove manufacturing involves process control and quality assurance, not data-driven model training.
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How the ground truth for the training set was established: Not applicable. See point 7.
§ 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.