(61 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 Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes the 510(k) submission for Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves. This information focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested categories for AI/ML study details are not applicable to this submission. However, I can extract the relevant information regarding acceptance criteria and non-clinical testing performed.
Here's the information derived from the provided text, adapted to your requested format where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (Standards Used for Glove Production) | Inspection level S-2, AQL 4.0 | Meets requirements for physical and dimensions testing. |
| Pinhole/Water Fill Test | FDA 1000 ml. Water Fill Test, AQL 2.5, inspection level I | Meets these requirements. |
| Primary Skin Irritation | Not explicitly stated, but implies "no primary skin irritant reactions" | No primary skin irritant reactions found. |
| Skin Sensitization (Allergic Contact Dermatitis) | Not explicitly stated, but implies "no sensitization reactions" | No sensitization reactions found. |
| Residual Powder Content (for "powder-free" claim) | ASTM D-6124-06 (no more than 2 mg powder per glove) | Our gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| General Standard Compliance | ASTM D-5250-06e1 standard | Conforms fully to ASTM D-5250-06e1 standard. |
| Biocompatibility | Not explicitly stated, but implied by skin irritation/sensitization tests | Biocompatibility requirements met as shown by data in Section 7. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. For physical and dimensions testing, "Inspection level S-2, AQL 4.0" is mentioned. For the FDA Water Fill Test, "AQL 2.5, inspection level I" is mentioned. These are statistical sampling plans, but not a direct number of samples.
- Data Provenance: Not specified (e.g., country of origin). The tests were performed by "Grand Work Plastic Products Co., Ltd.'s glove production," implying the testing was done by the manufacturer. The text does not indicate if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission details non-clinical laboratory and performance testing of physical characteristics and biocompatibility, not expert-adjudicated ground truth for AI/ML.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- The "ground truth" for the tests performed were established by adherence to ASTM standards, FDA testing procedures (e.g., Water Fill Test), and laboratory assays for biocompatibility (Primary Skin Irritation and Skin Sensitization) and residual powder. These are objective measurements against defined criteria.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there's no training set in that context. The devices are manufactured according to a process that undergoes quality control and testing.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.