(126 days)
A Powder Free Patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Black Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Black colour, powder free and non sterile.
This document is a 510(k) premarket notification for a medical device: "EMG Black Nitrile Medical Examination Glove Powder Free." It focuses on demonstrating the substantial equivalence of this new device to an existing legally marketed predicate device (K112924, RS Black Nitrile Medical Examination Gloves Powder Free).
The provided text does not describe an AI/ML-based medical device or any study involving AI/ML. Instead, it is a traditional medical device submission for examination gloves, which are physical products. Therefore, I cannot extract information related to:
- Acceptance criteria for an AI/ML device's performance.
- Sample sizes for test or training sets for AI/ML.
- Number of experts or their qualifications for AI/ML ground truth.
- Adjudication methods for AI/ML test sets.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI/ML.
- How ground truth for a training set was established for an AI/ML device.
The document contains information on:
1. Acceptance Criteria and Reported Device Performance (for the physical glove):
The acceptance criteria and reported performance are based on the ASTM D 6319-10 standard for Nitrile Examination Gloves and other relevant ASTM standards for physical and biological properties.
| Characteristic | Acceptance Criteria | Reported Device Performance (EMG Black Nitrile Medical Examination Gloves Powder Free, K141579) |
|---|---|---|
| Physical Dimensions | Meets ASTM D6319-10 | |
| - Overall Length (mm) | 230mm min | 230mm min (all sizes) |
| - Width (± 5mm) | S=85, M=95, L=105, XL=115 | S=85, M=95, L=105, XL=115 |
| - Thickness at Palm (mm) | 0.05mm min | 0.05mm min |
| - Thickness at Finger Tip (mm) | 0.05mm min | 0.05mm min |
| Physical Properties (Before Aging) | ||
| - Tensile Strength (MPa) | 14 min | Meets ASTM D6319-10 (14 min) |
| - Ultimate Elongation (%) | 500 min | Meets ASTM D6319-10 (500 min) |
| Physical Properties (After Aging at 70°C for 168 hrs @ 100°C for 22 hrs) | ||
| - Tensile Strength (MPa) | 14 min | Meets ASTM D6319-10 (14 min) |
| - Ultimate Elongation (%) | 400 min | Meets ASTM D6319-10 (400 min) |
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 |
| Biological Evaluation | ||
| - Primary Skin Irritation Test | Non-irritant | Test Article was a non-irritant |
| - Dermal Sensitization Assay | Non-sensitizer | Test Article was a non-sensitizer |
2. Sample size used for the test set and the data provenance:
The document implicitly refers to testing samples of gloves to meet the AQL (Acceptable Quality Level) standard for pinholes and other physical/biological tests. However, it does not specify the exact sample sizes used for these tests. The data provenance is from Malaysia, specifically from the manufacturing site of Eco Medi Glove SDN BHD. The data would be prospective as it's part of the premarket testing for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of medical device (physical examination gloves). Ground truth is established through standardized physical and chemical laboratory testing methods (e.g., ASTM standards), not expert interpretation.
4. Adjudication method for the test set:
Not applicable. Testing involves quantitative measurements and adherence to pass/fail criteria according to ASTM 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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
The ground truth is based on objective measurements and laboratory tests performed according to established industry standards (e.g., ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06) for physical properties (dimensions, tensile strength, elongation), freedom from pinholes, residual powder, and biological evaluations (skin irritation and sensitization).
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
§ 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.