(71 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 Classified by I DA's General Hospital and Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes a 510(k) submission for "Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Yellow" and focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on non-clinical tests to prove safety and efficacy, rather than clinical trials with human subjects or a focus on AI algorithm performance.
Therefore, many of the requested categories are either "Not Applicable" or cannot be extracted from the provided document.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D-5250-06e1 (General requirements for vinyl examination gloves, including physical and dimensional testing) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| "Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow conform fully to ASTM D-5250-06e1 standard." | |
| FDA 1000 ml. Water Fill Test (Pinhole detection) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level 1, meeting these requirements." |
| "meets pinhole FDA requirements." | |
| Primary Skin Irritation and Skin Sensitization testing | "Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| ASTM D-6124-06 (Residual Powder Test) | "A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the ASTM-related tests, the document mentions "Inspection level S-2, AQL 4.0" for physical/dimensional testing and "AQL 2.5, inspection level 1" for the water fill test. These are sampling plans, not explicit sample sizes. AQL (Acceptable Quality Level) and inspection levels refer to statistical sampling methods, but the exact number of gloves tested is not specified.
- Data Provenance: Not specified, but generally, such testing is conducted by the manufacturer or accredited labs on their product batches. The document does not specify country of origin for the data (beyond the manufacturer's country of origin being China) or if it's retrospective or prospective (implied prospective testing for lot release).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a medical glove, and its performance is assessed through standardized physical and chemical tests, not clinical evaluation requiring expert ground truth in the context of disease diagnosis or intervention.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3. Testing involves objective measurements against predefined standards.
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-enabled device, nor does it involve human readers interpreting medical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standardized Test Methods and Specifications: The "ground truth" for this device's performance is established by adhering to the specifications and pass/fail criteria defined in industry standards like ASTM D-5250-06e1, ASTM D-6124-06, and FDA-specific test methods (e.g., 1000 ml. Water Fill Test), as well as biological safety testing (skin irritation/sensitization).
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
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.