(112 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text describes the regulatory clearance for a medical device: "Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies. Therefore, much of the information typically requested for AI/algorithm-based devices (like the specifics of a study proving device meets acceptance criteria, sample sizes for training/test sets, expert involvement, and MRMC studies) is not applicable or detailed in this submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
The acceptance criteria are primarily based on established ASTM standards for patient examination gloves. The device performance is reported as meeting these requirements.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical and Dimensions | ASTM D5250-06 | Meets all requirements of ASTM D5250-06 |
| Watertightness | FDA 1000 ml Watertight Test (based on ASTM D-5151-06) with AQL 2.5, Inspection level I | Meets requirements |
| Powder Residue | ASTM D6124-06 (for "powder-free" claim) | Contains no more than 2 mg powder per glove |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | |
| Lead Content | (Implicit, due to mention) | May contain 1.00 ppm of lead |
Study Details
This document is a 510(k) summary for a Class 1 medical device (patient examination glove). The "study" described is a series of non-clinical tests to demonstrate conformance to established standards and substantial equivalence to a predicate device, rather than a clinical trial validating an AI algorithm.
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Sample size used for the test set and the data provenance:
- Watertightness Test: Sampling of AQL 2.5, Inspection level I. (No specific number of gloves given, but AQL and inspection level define the sampling plan.)
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (No specific number of gloves given.)
- Biocompatibility Testing: Not specified, but standard toxicological testing would involve animal models.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing by Xuzhou Full Sun Medical Products Ltd. in China, as per the manufacturer's location. The tests are "non-clinical."
- Retrospective/Prospective: Not applicable for these non-clinical tests.
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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. These tests involve objective measurements against physical and chemical standards, not subjective expert interpretation of complex data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests are based on objective, quantifiable measurements against ASTM 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 is a physical device (glove), not an AI algorithm for diagnostic imaging or similar applications.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device is defined by the objective pass/fail criteria established by the ASTM standards (e.g., tensile strength, elongation, watertightness, powder residue limit) and biocompatibility test results.
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The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.
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How the ground truth for the training set was established: Not applicable.
§ 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.