(46 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4 | All testing meets requirements for physical and dimensions testing. |
| Pinholes (Water Leak Test): FDA 1000 ml. Water Fill Test, AQL 2.5, Inspection Level I | Meets requirements. |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder: Based on ASTM D-6124-06 for Starch, no more than 10mg/dm² | Meets "powdered" claims (contains no more than 10mg/dm²). |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical and Dimensions Testing: Not explicitly stated as a fixed number, but refers to "samplings" and an "inspection level S-2" with "AQL 4.0". This implies a statistical sampling plan rather than a fixed sample size.
- Sample Size for Pinholes (Water Fill Test): Refers to "samplings of AQL 2.5, inspection level I". This also implies a statistical sampling plan.
- Sample Size for Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
- Sample Size for Residual Powder Test: Not explicitly stated.
- Data Provenance: The studies were conducted by Ever Light Plastic Products Co., Ltd. for their product. It is a prospective evaluation of their manufactured gloves. The country of origin of the data would be China, where the manufacturer is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water fill test) and expert judgment is not typically involved in the same way it would be for diagnostic imaging or clinical outcomes studies. The reported performance is based on direct measurements and observations during these tests.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., by multiple readers) to resolve discrepancies. For objective performance measures of medical gloves, such as physical properties, leak tests, or biocompatibility, direct measurements are taken, and no adjudication by multiple experts is required.
5. 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
This information is not applicable. This submission is for a medical device (patient examination gloves) that is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is of the physical and biological characteristics of the gloves themselves.
7. The type of ground truth used
The "ground truth" for the performance of these gloves is defined by:
- Performance specifications and testing methods outlined in ASTM-D-5250-00E4.
- FDA requirements for pinholes (1000 ml. Water Fill Test).
- Standardized biocompatibility testing for irritation and sensitization.
- Standardized testing method for residual powder (ASTM D-6124-06).
These standards define the acceptable range or threshold for each property, forming the objective "ground truth" for compliance.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of physical medical devices like examination gloves. The manufacturing process of gloves is not an AI model that requires training data. Instead, there are quality control and acceptance sampling processes during manufacturing.
9. How the ground truth for the training set was established
This information is 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.