(27 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 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 and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3
This document describes the validation of a medical device, specifically a "Powder Free Nitrile Blue Textured Examination Glove." However, it focuses on the physical and biological characteristics of the glove and its substantial equivalence to a predicate device, rather than the performance of an AI or software-based medical device.
Therefore, many of the requested categories (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission.
Here's the information that can be extracted and presented, with clarifications for the questions that don't apply:
Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing | Meets requirements of ASTM standard D-6319-00€3. Inspection level S-2, AQL 4.0. |
| Water Fill Test (Pinhole) | Meets requirements of the FDA 1000 ml. Water Fill Test with samplings of AQL 2.5, inspection level G-1. |
| Primary Skin Irritation | Results show no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Results show no sensitization reactions. |
| Residual Powder | Meets "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D-6124-01 for Starch at finished inspection. |
| Compliance with ASTM Standard | Conforms fully to ASTM D-6319-00E standard. |
| Compliance with 21 CFR References | Conforms fully to applicable 21 CFR references (specifically 21 CFR 880.6250, specifying Class I, Power-Free Nitrile Patient Examination Glove, 80 LZA). |
| Labeling Claims | No special labeling claims; does not claim gloves as hypoallergenic. (This is a statement of compliance with labeling requirements rather than a performance metric, but it confirms adherence to the device description). |
Study Details (as applicable for a physical medical glove)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single "test set" for performance evaluation in the way a software algorithm would be. Instead, testing was conducted on samples from manufacturing lots based on AQLs (Acceptable Quality Levels).
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
- Water Fill Test: AQL 2.5, inspection level G-1.
- Data Provenance: Not specified, but generally, such testing would be conducted by the manufacturer (Syntex Healthcare Products Co., Ltd.) in China, where the device is manufactured. The testing is likely retrospective in the sense that it's performed on finished products, but it represents ongoing quality control.
- Sample Size: Not explicitly stated as a single "test set" for performance evaluation in the way a software algorithm would be. Instead, testing was conducted on samples from manufacturing lots based on AQLs (Acceptable Quality Levels).
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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 a physical glove is determined by established physical and chemical test methods against defined standards (ASTM, FDA). It does not involve expert consensus in the way an AI diagnostic tool would for clinical images.
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Adjudication method for the test set:
- Not Applicable. Pertains to expert review for ambiguous cases in diagnostic studies, not physical product testing.
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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, disposable medical device, not an AI software.
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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, disposable medical device, not an AI algorithm.
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The type of ground truth used:
- Established Standards and Test Methods: The ground truth for this device's performance is based on recognized consensus standards (ASTM D-6319-00€3, ASTM D-6124-01) and regulatory test methods (FDA 1000 ml. Water Fill Test), as well as biocompatibility testing for skin irritation and sensitization.
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The sample size for the training set:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
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How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI algorithm.
§ 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.