(78 days)
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.
Class 1 vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92.
This submission is for a medical device called "GG" vinyl examination gloves, powder-free, which falls under the classification of Patient examination glove (per 21 CFR 880.6250). The device is intended for medical purposes as a disposable item worn on the examiner's hand or finger to prevent contamination between the patient and examiner.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "GG" vinyl examination gloves, powder-free, are based on the ASTM standard D 5250 - 92, and FDA pinhole requirements. The document indicates that the device's performance "meets or exceeds the ASTM or equivalent standard" and "meets FDA pinhole requirements."
| Acceptance Criteria (Based on ASTM D 5250 - 92 and FDA Pinhole Requirements) | Reported Device Performance |
|---|---|
| Dimension and Tolerance (Inspection level S-2, AQL 4.0) | Meets/Exceeds ASTM D 5250 |
| * Width (S, M, L, XL sizes) | Meets/Exceeds ASTM D 5250 |
| * Length (All sizes) | Meets/Exceeds ASTM D 5250 |
| Physical Requirements (Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. Inspection level S-2, AQL 4.0) | Meets/Exceeds ASTM D 5250 |
| * Tensile strength (Mpa, min) | 9.0 (Minimum required 9.0) |
| * Ultimate Elongation (%, min) | 300 (Minimum required 300) |
| Pinhole Requirements | Meets FDA pinhole requirements |
Note on "Reported Device Performance": The provided text explicitly states that the gloves "meet or exceed the ASTM or equivalent standard" and "meet FDA pinhole requirements." For specific numerical criteria like tensile strength and ultimate elongation, the document lists the reported values as 9.0 Mpa (min) and 300% (min) respectively, which directly match the minimum requirements. For dimension and tolerance, the table simply states "Meets/Exceeds ASTM D 5250" as specific measured values for each size are not provided, only the general standard of compliance.
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set in the same way clinical trials report them. Instead, it refers to "Inspection level S-2, AQL 4.0" for both dimension and tolerance and physical requirements. These are sampling plans specified in quality control standards (like ISO 2859-1 or MIL-STD-105E, of which AQL is a part) for attribute sampling.
- Sample Size for Test Set: Not explicitly stated as a number of devices/gloves. It refers to "Inspection level S-2, AQL 4.0," which defines a sampling plan from which sample sizes are derived based on batch size. The specific sample size for a given batch size would need to be looked up in the relevant AQL tables.
- Data Provenance: The data is generated from the manufacturer in Taiwan, R.O.C. (General Gloves Corp., No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733). The data appears to be prospective as it involves performance testing of the manufactured product against established standards.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable in the context of this device. The ground truth for examination gloves is based on established engineering and material standards (like ASTM D 5250 - 92) and regulatory requirements (like FDA pinhole requirements), not on expert consensus or interpretation of medical images. The "experts" are the engineers and quality control personnel performing the tests according to the standard operating procedures derived from ASTM.
4. Adjudication Method for the Test Set
This is not applicable for this type of device testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where there's subjectivity and potential for disagreement among human readers or interpreters. For physical and dimensional testing of gloves against a standard, the results are typically quantitative measurements or pass/fail criteria based on objective methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study assesses the effectiveness of human readers (e.g., radiologists) with and without AI assistance in diagnostic tasks. Since this device is a physical examination glove, there are no "human readers" in a diagnostic context, and therefore, no AI assistance to compare.
6. Standalone (Algorithm Only) Performance
This is not applicable. This device is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
The ground truth for the device's performance is based on established engineering standards and regulatory requirements. Specifically:
- ASTM D 5250 - 92: This standard defines the requirements for dimensions, tensile strength, and ultimate elongation for vinyl patient examination gloves.
- FDA Pinhole Requirements: These are regulatory standards for the barrier integrity of examination gloves.
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" and "test set" in the context of machine learning or AI is not relevant to the evaluation of a physical product like examination gloves. The manufacturing process of gloves does not involve machine learning models that are "trained."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8. There is no training set in the context of this device's regulatory submission.
§ 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.