(121 days)
Powder free vinyl 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.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Material Formulation | Poly vinyl chloride | Same |
| Manufacturing | PU Treatment (lack of donning powder) | Same |
| Dimensions | ASTM Standard D 5250-06 | Meets ASTM D5250-06 |
| Physical Properties | ASTM Standard D 5250-06 | Meets ASTM D5250-06 |
| Freedom from Pinhole | 21 CFR 800.20 | Meets 21 CFR 800.20 and FDA requirements for waterleak test on pinhole AQL. |
| Powder Residual | ASTM Standard D 5250-06 and D6124-06 | Meets ASTM D5250-06 and D6124-06 |
| Biocompatibility | No Primary Skin Irritation | |
| No Dermal sensitization | Same | |
| Overall Comparison | Substantially equivalent to predicate device (K032908) in safety, effectiveness, and performance. | "It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims. It is as safe, as effective, and performed as well the legally marketed device identified in (a)(3)." |
Study Information for Device Performance
Based on the provided 510(k) summary, the device's performance was evaluated through non-clinical testing. There was no mention of a clinical study being conducted or relied upon for this specific submission, as stated: "Clinical data is not needed for gloves or for most devices cleared by the 510(k) process."
Here's the detailed breakdown of the non-clinical testing:
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size used for each non-clinical test (e.g., how many gloves were tested for pinholes, or for physical properties).
- Data Provenance: Not explicitly stated beyond "non-clinical testing data that was submitted, referenced or relied on". The manufacturer is in China, so the testing was likely conducted by or for the manufacturer. Whether the data is retrospective or prospective for the current submission is implied as prospective testing to demonstrate compliance with current standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For non-clinical, objective tests (like physical properties or pinhole detection), "experts" in the sense of clinical specialists establishing ground truth are typically not required. Instead, adherence to standardized test methods (e.g., ASTM standards) by qualified laboratory personnel is expected.
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Adjudication method for the test set:
- Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments. For the non-clinical, objective tests described (e.g., ASTM standards, 21 CFR 800.20 for freedom from pinholes), adjudication in this context is not applicable. Pass/fail criteria are defined by the standards themselves.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers, which is not the case for patient examination gloves.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is not an algorithm or AI system. Its performance is based on intrinsic material and manufacturing characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is derived from established industry standards and regulatory requirements.
- ASTM D5250-06: Specifies requirements for vinyl patient examination gloves.
- ASTM D6124-06: Specifies test methods for residual powder on medical gloves.
- 21 CFR 800.20: Pinhole requirements for patient examination gloves (water leak test).
- ISO10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
- The "ground truth" for the non-clinical tests is derived from established industry standards and regulatory requirements.
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The sample size for the training set:
- Not applicable. This is a physical medical device (patient examination gloves), not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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.