(154 days)
The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.
Here's the summary of the acceptance criteria and reported device performance:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance (Non-Sterile, Powder Free Nitrile Examination Gloves) |
|---|---|---|
| Dimension | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from holes | ASTM D6319-10 (GII AQL = 2.5) & FDA 1000ml Water Leak Test | Meets (0 holes found in sample size of 80 for all models, with accept criteria of 5 and reject criteria of 6) |
| Length (mm) for Size M | Min 230 | 240-253 (range across all models) |
| Palm Width (mm) for Size M | 95 ± 10 | 95-99 (range across all models) |
| Thickness (mm) Finger (single layer) | Min 0.05 | 0.08-0.16 (range across all models) |
| Thickness (mm) Palm (single layer) | Min 0.05 | 0.06-0.12 (range across all models) |
| Powder-free | ASTM D6319-10 | Meets |
| Moisture Content (%) | Max 2.0% | 0.8% - 1.2% (Average across all models) |
| Residual Powder (mg/glove) | Max 2.0mg/glove (ASTM-D6124-10) | 0.10mg/l - 0.20mg/glove (range across all models; presented as a percentage in one instance for residual powder and mg/glove for moisture content) |
| Biocompatibility | Primary skin irritation: ISO 10993-10 (Non-Irritant) | |
| Dermal Sensitization: ISO 10993-10 (Non-sensitizer) | Non-Irritant | |
| Non-sensitizer (for all models) |
Study Proving Device Meets Acceptance Criteria:
The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).
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Standards Used: The performance of the devices was evaluated against the following standards:
- ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
- FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
- ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
- ASTM-D6124-10 (Reapproved 2011) for Residual Powder.
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Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.
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
This information is not applicable as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.
9. How the ground truth for the training set was established
This information is not applicable as the device 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.