(125 days)
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and the study that demonstrates the device meets these criteria. The device in question is the Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination Gloves - Powdered.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Acceptance Standard (if specified) | Reported Device Performance |
|---|---|---|
| Physical Dimensions and Testing | ASTM Standard D5250-92 | Meets all requirements for Physical Dimensions and Testing (Inspection Level S-2, AQL 4.0) |
| Integrity (Pinhole) | FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level S-4) | Meets all requirements of the FDA 1000 ml. Water Fill Test |
| Biocompatibility (Primary Skin Irritation) | Not explicitly stated, implied by "no primary skin irritant reactions" | No primary skin irritant reactions observed |
| Biocompatibility (Skin Sensitization) | Not explicitly stated, implied by "no sensitization reactions" | No sensitization (allergic contact dermatitis) reactions observed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of an algorithm or AI model, as this is a medical device (gloves). Instead, the listed tests refer to quality control and performance testing for the manufacturing and physical properties of the gloves.
- Physical Dimensions and Testing: Inspection Level S-2, AQL 4.0. The exact sample size for this inspection level is not provided but is a standard statistical sampling plan for quality control.
- FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size for this inspection level is not provided but is a standard statistical sampling plan for quality control.
- Primary Skin Irritation and Skin Sensitization: The sample size for these biocompatibility tests is not specified in the provided text.
- Data Provenance: The tests were conducted by Sunmax Enterprise Shanghai Co., Ltd. in China. The document does not specify if the data is retrospective or prospective, but given the context of product testing for 510(k) submission, it would generally be prospective testing conducted on new production batches.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical medical device (gloves), not an AI/algorithm-driven device requiring expert-established ground truth for a test set. The performance is assessed against established physical and biocompatibility standards.
4. Adjudication Method
Not applicable. As this involves physical device testing against established standards, an adjudication method for reconciling different expert opinions on ground truth is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical medical device (gloves), not an AI system that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (gloves), not an algorithm or software. Its performance is inherent to its physical properties and material.
7. Type of Ground Truth Used
The "ground truth" for the performance of these gloves is established by:
- Standard Specifications: Compliance with ASTM Standard D5250-92 for physical dimensions and testing.
- Regulatory Test Methods: Compliance with the FDA 1000 ml. Water Fill Test for pinhole integrity.
- Biocompatibility Testing: Results from primary skin irritation and skin sensitization tests, which are objective measures of biological response.
8. Sample Size for the Training Set
Not applicable. As this is a physical medical device (gloves), there is no "training set" in the context of machine learning or algorithm development. The "training" for glove manufacturing would involve process control and quality assurance to ensure consistent product output.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an algorithm. The manufacturing process of the gloves is designed and controlled to meet the established standards and specifications, which serve as the "ground truth" for product quality. This is established through engineering design, material specifications, quality management systems (e.g., FDA's GMPs), and adherence to industry standards like ASTM.
§ 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.