(51 days)
A patient examination glove is a disposable device intended for medical purposes that 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 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 and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00€4.
The provided text describes a 510(k) submission for powdered vinyl patient examination gloves. As such, it is not a study about a software-based AI/ML driven medical device, and therefore the requested information regarding acceptance criteria and studies tailored to such devices is largely inapplicable.
The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (gloves). The typical performance metrics, study designs (e.g., MRMC, standalone), and ground truth establishment methods for AI/ML devices are not relevant here.
However, I can extract the information that is provided and explain why other requested details are not present.
Inapplicability Note:
The provided text describes the regulatory filing for a physical medical device (powdered vinyl patient examination gloves) and not a software-based AI/ML device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable to this type of device and are not detailed in the provided 510(k) summary. The "acceptance criteria" here refer to conformance with established standards for physical properties and safety, not statistical performance metrics of an algorithm.
Extracted Information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Compliance) |
|---|---|---|
| Physical and Dimensions | ASTM-D-5250-00E4 | Meets all requirements, Inspection Level S-2, AQL 4.0 |
| Pinhole/Water Leak Test | FDA 1000 ml. Water Fill Test | Meets requirements, AQL 2.5, Inspection Level I |
| Biocompatibility (Irritation) | Primary Skin Irritation Test | No primary skin irritant reactions |
| Biocompatibility (Sensitization) | Skin Sensitization Test (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder | ASTM D-6124-06 for Starch | Meets "powdered" claims (contains no more than 10mg/dm2) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set:
- Physical and Dimensions: Inspection Level S-2, AQL 4.0 (specific sample size from lot not provided, but these are standard sampling plans).
- Pinhole/Water Fill Test: AQL 2.5, Inspection level I (specific sample size from lot not provided, but these are standard sampling plans).
- Biocompatibility: Not explicitly stated how many subjects/samples were used, but standard tests were conducted.
- Residual Powder: Not explicitly stated how many samples were used, but conducted at finished inspection.
- Data Provenance: Not explicitly stated, implied to be laboratory testing conducted by or for Super Safe Plastic Products Co., Ltd. (China). Retrospective for the purposes of this submission, as the tests were performed prior to submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not Applicable. For a physical device like examination gloves, "ground truth" as understood in AI/ML performance studies does not apply. Performance is assessed against established physical and chemical standards and biocompatibility tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) in AI/ML studies. Here, compliance is determined by objective measurements and standardized tests against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is for evaluating AI assistance to human readers, which is not relevant for a physical examination glove.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This device is not an algorithm. Performance is inherent to the physical product and its manufacturing process.
7. Type of Ground Truth Used
- Established Standards/Objective Measurements: For aspects like physical dimensions, pinhole defects, residual powder, the "ground truth" is adherence to predefined specifications within recognized industry standards (ASTM D-5250-00E4, ASTM D-6124-06) and regulatory requirements (FDA Water Fill Test). For biocompatibility, it's the observed biological response to the product in standard tests.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set." The manufacturing process involves continuous quality control and testing against established product specifications.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 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.