(53 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 on 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.
The provided text describes the 510(k) submission for "Zibo Boxiang Plastic & Rubber Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free". This submission focuses on establishing substantial equivalence to a predicate device for a Class I medical device (patient examination gloves). As such, the testing and evaluation approach differs significantly from what would be expected for a complex AI/ML-driven diagnostic or medical imaging device.
Therefore, many of the requested categories in your prompt are not applicable in this context. The study described is not for an AI/ML algorithm or a device requiring complex performance metrics like sensitivity, specificity, or reader studies. Instead, it's about meeting established physical and biocompatibility standards for a commodity medical product.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | Meets requirements of ASTM-D-5250 (Inspection Level S-2, AOL 2.5) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5. Conforms fully to ASTM-D-5250 standard. |
| Pinhole/Leakage Test | Meets FDA 1000 ml. Water Fill Test requirements (AOL 2.5, Inspection Level I) | FDA 1000 ml. Water Fill Test conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements. Meets pinhole FDA requirements. |
| Biocompatibility (Skin Irritation) | No primary skin irritant reactions | Primary Skin irritation testing was conducted with results showing no primary skin irritant reactions. |
| Biocompatibility (Skin Sensitization) | No sensitization reactions (allergic contact dermatitis) | Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitization reactions. |
| Powder-Free Claim | Contains no more than 2 mg powder per glove | Testing is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove). |
Study Proving Device Meets Acceptance Criteria:
The study described is a series of non-clinical tests performed on the Zibo Boxiang Plastic & Rubber Co., Ltd. Synthetic Vinyl Patient Examination Gloves to demonstrate their adherence to established industry standards and FDA requirements.
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Sample size used for the test set and the data provenance:
- Sample Size:
- For Physical and Dimensions Testing: Inspection Level S-2, AOL 2.5 (The exact number of units is not specified but refers to the sampling plan under ASTM-D-5250).
- For FDA 1000 ml Water Fill Test: Inspection Level I, AOL 2.5 (The exact number of units is not specified but refers to the sampling plan under the FDA test).
- For Primary Skin Irritation and Skin Sensitization: Not specified, but standard biological evaluation tests would typically use a certain number of animal models or human volunteers as per ISO 10993 guidelines, which are implied for biocompatibility.
- Data Provenance: Not explicitly stated (e.g., country of origin for the tested batches), but the manufacturing company is Zibo Boxiang Plastic & Rubber Co., Ltd. in Zibo, Shandong, China. The tests are "non-clinical tests performed for Determination of Substantial Equivalence." These are tests on the device itself, not patient data.
- Sample Size:
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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):
- Not Applicable. This is not a study requiring expert interpretation or "ground truth" establishment in the sense of clinical diagnoses or image analysis. The "ground truth" here is objective physical and chemical measurements governed by established standards (ASTM-D-5250, FDA water fill test, biocompatibility tests). The experts involved would be laboratory technicians and engineers performing these specific tests, likely qualified in materials science, chemistry, and biocompatibility testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in clinical trials or reader studies). The tests performed for these gloves involve objective measurements against pass/fail criteria, not subjective interpretations requiring adjudication.
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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. No MRMC study was conducted. This device is a patient examination glove, not an AI-assisted diagnostic tool.
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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 (gloves), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Standards and Measurements: The "ground truth" for this device's performance is defined by:
- ASTM-D-5250 Standard: Specifications for physical properties, dimensions, and visual defects.
- FDA 1000 ml. Water Fill Test: A specific test protocol for pinhole detection.
- Biocompatibility Standards (implied): For primary skin irritation and sensitization, usually ISO 10993 series or equivalent guidelines are followed, which define criteria for judging a material's biological safety.
- Gravimetric Analysis: For the "powder-free" claim (measuring powder residue).
- Objective Standards and Measurements: The "ground truth" for this device's performance is defined by:
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The sample size for the training set:
- Not Applicable. This type of device does not involve a "training set" in the context of machine learning or algorithm development. The manufacturing process of the gloves is based on quality control and adherence to standards for each production batch.
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How the ground truth for the training set was established:
- Not Applicable. As there's no training set, this question is not relevant.
§ 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.