(70 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D5250-06e1.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance/Compliance |
|---|---|
| ASTM D5250-06e1 Standard Compliance | "conform fully to ASTM D5250-06e1 standard" |
| Physical and Dimensions Testing | "All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0." |
| FDA 1000 ml Water Fill Test (Pinhole) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level 1, meeting these requirements." |
| Primary Skin Irritation | "results showing no primary skin irritant" |
| Skin Sensitization (Allergic Contact) | "results showing no... sensitization reactions." |
| Residual Powder (Powder-Free Claim) | "meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility requirements | "meets... biocompatibility requirements" (General statement, likely referring to skin irritation/sensitization tests) |
| Labeling Claims | "meets... labeling claims" (No special claims, not hypoallergenic) |
Study Information
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Sample sizes used for the test set and the data provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
- FDA 1000 ml Water Fill Test (Pinhole): AQL 2.5, inspection level 1. (No specific number of gloves given for the test set, but AQL and inspection level define the sampling plan.)
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but typically involves a certain number of human subjects or animal models according to the test standards.
- Residual Powder Test: Not explicitly stated.
- Data Provenance: Not specified, but generally refers to in-house laboratory testing by the manufacturer or a contracted lab. The document implies the tests were conducted by or for Hongze Plastic Technology Co., Ltd.
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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 are objective physical and chemical tests, not diagnostic or subjective evaluations requiring expert consensus for ground truth.
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Adjudication method for the test set:
- Not applicable. The tests are based on objective pass/fail criteria from ASTM standards and FDA requirements.
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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 device is a patient examination glove, not an AI-powered diagnostic or assistive 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/standards: The ground truth for these tests is established by the specified ASTM standards (D5250-06e1, D-6124-06) and FDA requirements (1000 ml Water Fill Test). These standards define acceptable ranges for physical properties, maximum defect rates (AQL), and chemical residue levels. Biocompatibility (irritation/sensitization) also has established clinical/toxicological parameters for "no reaction."
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The sample size for the training set:
- Not applicable. There is no machine learning or AI component that would require a training set. The "training" here refers to the manufacturing process adhering to quality control standards.
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How the ground truth for the training set was established:
- Not applicable, as no training set for AI is involved. The manufacturing process is geared towards meeting established product specifications and quality standards defined by ASTM and regulatory bodies.
§ 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.