(55 days)
A glove 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 a disposable device intended for medical purposes 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, Pre-powder Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Here's an analysis of the provided text to extract the acceptance criteria and study information, formatted as requested:
Device: SHANGHAI HUAMAO GLOVES CO., LTD. Pre-powder Vinyl Examination Gloves
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM Standard D5250-92 | All testing meets requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0. Conforms fully to ASTM D-5250-92 standards. |
| FDA 1000 ml. Water Fill Test | Samplings of AQL 2.5, Inspection Level S-4, meeting these requirements (pinhole FDA requirements). |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Compliance with FDA's GMPs | Operates in compliance with FDA's GMPs. |
| Bio-compatibility requirements | Met (as shown by data in Section 7). |
| Labeling claims | Met (as shown by data in Section 7). |
| Applicable 21 CFR references | Conforms fully. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Physical and Dimensions Testing): Not explicitly stated as a number, but "Inspection Level S-2, AQL 4.0" is mentioned, which refers to a sampling plan for inspection.
- Sample Size (FDA 1000 ml. Water Fill Test): Not explicitly stated as a number, but "samplings of AQL 2.5, Inspection Level S-4" is mentioned, which refers to a sampling plan for inspection.
- Data Provenance: The device manufacturer is SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was conducted based on ASTM standards (likely in China or by a certified lab). It is implicitly retrospective as it's a premarket notification for a manufactured product.
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 (examination gloves), and its performance is evaluated against established technical standards (ASTM, FDA water fill test, biocompatibility). Expert consensus for "ground truth" in the way it's used for AI or diagnostic devices is not relevant here. The evaluation is based on objective measurements and tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted here (physical dimensions, water fill, irritation, sensitization) are objective.
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 a diagnostic device or an AI-assisted tool. It's a medical device (examination glove) with performance evaluated against industrial and regulatory standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the specified values and requirements set by the adopted standards:
- ASTM Standard D5250-92: This standard defines the physical properties and dimensions for vinyl patient examination gloves.
- FDA 1000 ml. Water Fill Test: This is a specific FDA requirement for assessing pinhole defects in gloves.
- Biocompatibility Standards: These standards (implied, as "biocompatibility requirements" are mentioned) define acceptable levels of skin irritation and sensitization.
Essentially, the ground truth is defined by the established performance specifications and testing methodologies outlined in the regulatory and industry standards.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI models, so there is no training set. The "training set" concept is irrelevant for a physical product like examination gloves.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.