(49 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and 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 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
The provided text is for a 510(k) summary for medical gloves, which are low-risk devices and do not typically involve the types of studies and acceptance criteria that are relevant to AI/ML-powered medical devices. Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, and expert ground truth establishment, is not applicable.
Here's the information that can be extracted or deduced from the provided document, formatted to best fit the request for an AI/ML device, with explanations where the information is not directly applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Shijiazhuang Great Eagle Plastic Products Co., Ltd. glove production standards are based on ASTM-D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. |
| Pinhole Detection (Water Fill Test): | The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Biocompatibility (Primary Skin Irritation): | Primary Skin Irritation testing was conducted with results showing no primary skin irritant reactions. |
| Biocompatibility (Skin Sensitization): | Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no sensitization reactions. |
| Overall Conformance to Standards: | Conform fully to ASTM-D-5250-92 standards as well as applicable CFR 21 pinhole references, and meets FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing. These are statistical sampling plans from ASTM standards, not a fixed sample size in the context of typical AI/ML test sets. The exact number of gloves tested for each lot would depend on the size of the manufacturing lot.
Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in China. The data is from non-clinical testing performed by the manufacturer to demonstrate compliance with standards. It is implicitly retrospective in the sense that the tests were performed on manufactured batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for medical gloves is established by objective physical and chemical tests (e.g., water leak tests, measurements of dimensions, chemical assays for irritation). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of images or data to establish ground truth in diagnostic studies. For glove testing, the results are typically quantitative measurements or pass/fail criteria against established 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 device is a medical glove, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurement against established industry and regulatory standards. Specifically:
- Physical and Dimensional Characteristics: Defined by ASTM-D-5250-92.
- Barrier Integrity (Pinhole): Defined by FDA 1000 ml. Water Fill Test (referencing CFR 21 pinhole references) and ASTM-D-5250-92.
- Biocompatibility: Established through Primary Skin Irritation and Skin Sensitization testing, performed to determine the absence of adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance to meet the specified standards across all production.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML training set, there is no ground truth to be established in this context. The "ground truth" equivalent for manufacturing is the adherence to the ASTM-D-5250-92 standard and internal quality specifications during the production process.
§ 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.