(171 days)
Powdered 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed,
This is a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)". This type of device does not involve AI/ML technology, imaging, or diagnostics, and therefore the requested information regarding AI/ML study design, reader studies, and ground truth establishment is not applicable. The device is a Class I medical device, which typically relies on established performance standards and non-clinical testing for substantial equivalence.
Here's the relevant information from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM Standard D 5250-00e4 | Meets |
| Physical Properties | ASTM Standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM Standard D 5250-00e4 | Meets |
| Biocompatibility: | ||
| Contact to skin (e.g. skin irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Hypersensitivity | Dermal sensitization in the guinea pig | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to meeting established ASTM standards and CFR regulations for glove performance. These standards prescribe specific test methods and sample sizes. For example:
- Freedom from pinholes (21 CFR 800.20): This regulation specifies an Acceptable Quality Level (AQL) which implicates a statistically derived sample size for testing.
- ASTM D5250-00e4 (Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application): This standard outlines specific test methods and the number of specimens required for various tests like dimensions, physical properties (tensile strength, elongation), and powder amount. The document does not provide the specific number of gloves tested for this submission, but it implies compliance with the sampling requirements of these standards.
- Biocompatibility tests (ISO10993-10): These tests also have defined sample sizes for animal models (rabbits for skin irritation, guinea pigs for sensitization).
The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, but it's generated by the manufacturer, SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD, based in China, for submission to the FDA in the USA.
3. 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 device is a physical product (gloves), and performance is assessed against standardized physical and chemical tests rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML or diagnostic device that requires expert adjudication for ground truth.
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
Not applicable. MRMC studies are for diagnostic devices, particularly those involving human readers and AI assistance. This is a medical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on pre-defined, objective, and standardized measurements as specified by the referenced ASTM standards (e.g., D 5250-00e4, D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). For example:
- Physical properties (tensile strength, elongation) are measured objectively.
- Freedom from pinholes is determined by a water leak test.
- Biocompatibility is determined by standardized animal tests with observable outcomes (absence of irritation or sensitization).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.
§ 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.