(455 days)
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.
Here's the information based on the provided text, focusing on the non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties (Before Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 18.0 MPa | XS: 24.40 MPa, S: 24.56 MPa, M: 27.18 MPa, L: 26.51 MPa, XL: 26.11 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 650% | XS: 792 %, S: 808 %, M: 817 %, L: 811 %, XL: 783 % | Pass |
| Stress at 500% Elongation | ASTM D412 | Max. 5.5 MPa | XS: 4.77 MPa, S: 5.11 MPa, M: 4.55 MPa, L: 4.85 MPa, XL: 5.22 MPa | Pass |
| Physical Properties (After Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 14.0 MPa | XS: 25.59 MPa, S: 22.37 MPa, M: 27.16 MPa, L: 25.95 MPa, XL: 26.67 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 500% | XS: 802 %, S: 723 %, M: 809 %, L: 829 %, XL: 785 % | Pass |
| Dimension | ASTM D3767 (Rubber Measurement of Dimensions) | |||
| Length | ASTM D3767 | Min 240 mm (for all sizes) | XS: 243 mm, S: 243 mm, M: 243 mm, L: 243 mm, XL: 243 mm | Pass |
| Width | ASTM D3767 | XS: Max 80 mm, S: Min 80 ± 10 mm, M: Min 95 ± 10 mm, L: Min 110 ± 10 mm, XL: Min 110 mm | XS: 78 mm, S: 84 mm, M: 95 mm, L: 106 mm, XL: 116 mm | Pass |
| Thickness (Finger) | ASTM D3767 | Min 0.11 mm | XS: 0.14 mm, S: 0.14 mm, M: 0.15 mm, L: 0.15 mm, XL: 0.16 mm | Pass |
| Thickness (Palm) | ASTM D3767 | Min 0.09 mm | XS: 0.12 mm, S: 0.12 mm, M: 0.12 mm, L: 0.12 mm, XL: 0.13 mm | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Inspection Level 1, AQL 1.0 (Acceptance no. 5 for 200 pcs, Acceptance no. 10 for 500 pcs) | XS: Found 0 leaks (Sample 200), S: Found 1 leak (Sample 500), M: Found 3 leaks (Sample 500), L: Found 3 leaks (Sample 500), XL: Found 3 leaks (Sample 200) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Powder residue limit of 2.0 mg per glove | XS: 0.2 mg, S: 0.5 mg, M: 0.1 mg, L: 0.1 mg, XL: 0.2 mg | Pass |
| Extractable Protein Content | ASTM D5712-99 (Protein in Natural Rubber) | 200 µg/dm² Max | Less than 50 µg/dm² | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
- Dimension: Data is provided for each size (XS, S, M, L, XL).
- Watertight:
- XS & XL: Sample size 200 pcs each.
- S, M, L: Sample size 500 pcs each.
- Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
- Residual Powder: Sample size: 5 pcs.
- Extractable Protein Content: Sample size: 3 pcs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (glove), not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Study Type:
The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.
§ 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.