(14 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
The provided submission (K050529) is for a medical device that does not involve artificial intelligence (AI). It is a 510(k) premarket notification for "Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim." As such, the concept of a "device" in this context refers to the examination gloves themselves, and the acceptance criteria and supporting study are related to the physical and performance characteristics of these gloves, not an AI algorithm.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this type of medical device submission.
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D3578-01aE2 or FDA) | Reported Device Performance (Polymer Coated Powder Free Latex Exam Gloves) |
|---|---|---|
| Watertight (1000 ml) | AQL=2.5% Pass GI | Pass GI (AQL=2.5%) |
| Length (mm) - All Sizes | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) - Size XS | - | 110 mm |
| Thickness (mm) - Finger (Single Layer) | Min 0.08 | 0.10 minimum |
| Thickness (mm) - Palm (Single Layer) | Min 0.08 | 0.10 minimum |
| Physical Properties - Before Aging | ||
| Tensile Strength (Mpa) Before Aging | Min 14.0 | 21.1 |
| Ultimate Elongation (%) Before Aging | Min 650 | 817 |
| Physical Properties - After Aging | ||
| Tensile Strength (Mpa) After Aging | Min 14.0 | 16.7 |
| Ultimate Elongation (%) After Aging | Min 500 | 758 |
| Powder Content | Below 2mg / glove (FDA Requirements) | Below 2mg / glove |
| Protein Content | Below 50 microgram / gram (FDA Requirements) | Below 50 microgram / gram |
| Biocompatibility (Primary Dermal Irritation, Guinea Pig Sensitization) | Pass (implied by statement) | Pass |
2. Sample size used for the test set and the data provenance:
- The document refers to "Performance data of gloves based on ASTM D3578-01 a22 FDA 1000 ml watertight test." and "The average result obtained from Attachment C." However, the exact sample size used for the performance tests (e.g., watertightness, physical properties, thickness) is not explicitly stated in the provided text. ASTM D3578-01aE2 specifies an AQL (Acceptable Quality Level) of 2.5%, implying a statistical sampling plan (e.g., ISO 2859-1 or similar), but the specific number of units tested is not provided.
- Data Provenance: The manufacturing entity is "SPI GLOVES SDN. BHD." located in Malaysia. The tests conducted would presumably be performed on gloves produced in Malaysia.
3. 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 glove performance is established through standardized laboratory testing against objective criteria (e.g., measurements for length and thickness, tensile testing for physical properties, chemical analysis for powder and protein content, and standardized water leak tests). There is no "expert" (like a radiologist) establishing a subjective truth.
4. Adjudication method for the test set:
- Not applicable. Performance data is derived from objective measurements and standardized tests, not subjective interpretations requiring adjudication.
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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- Objective measurement and standardized test results against established engineering and chemical specifications (ASTM D3578-01aE2 for physical properties, FDA requirements for watertightness, powder content, and protein content).
- Biocompatibility testing (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) against established biological safety standards.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in the AI sense. The manufacturing process of the gloves could be considered "trained" through quality control and process optimization over time, but not in the context of a "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI 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.