(99 days)
Blue Colour, Chlorinated Powder Free Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
The Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application1. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are blue in color and are powder free.
The provided FDA 510(k) summary is for a medical device that is not an AI/ML powered device. The device is "BLUE COLOUR, CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES." Therefore, the requested information regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, is not applicable to this submission.
The summary describes the device's adherence to established standards for examination gloves.
Here's a breakdown of the relevant information provided for this non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| All current specifications listed under ASTM D 6319 - 00a | Gloves meet all current ASTM D 6319-00a specifications. Including: |
| Absence of irritation (Primary skin irritation testing in the rabbit) | No irritation |
| Absence of sensitization (Delayed dermal contact sensitization study in the guinea pigs) | No sensitization |
| Performance and biocompatibility requirements | Meets all performance and biocompatibility requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Non-Clinical Tests: Not explicitly stated in terms of an exact number of gloves. The studies refer to "testing performed per ASTM D 6319 - 00a," and "Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs." ASTM standards typically specify sampling plans, but the specific numbers for this submission are not detailed.
- Data Provenance: The manufacturing company, MEDTEXX MANUFACTURING SDN. BHD., is located in Malaysia. The testing would presumably be conducted by or for this manufacturer. The nature of these tests (material properties, biological safety) makes the "origin of data" less about observational patient data and more about laboratory and animal testing. These are inherently prospective tests on the product itself.
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 question is not applicable as the device is not an AI/ML system that requires expert interpretation to establish a ground truth. The "ground truth" for these gloves is their physical properties and biological safety as measured by established laboratory and animal testing protocols, which are objective and do not rely on human expert consensus interpretation of complex data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations or complex diagnostic tasks where multiple human readers might disagree. The tests performed for examination gloves are standardized physical and biological assays.
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 question is not applicable as the device is not an AI/ML system and does not involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on objective measurements and observations from standardized physical, chemical, and biological tests following ASTM D 6319 - 00a and 21 CFR 800.20. This includes:
- Physical properties (e.g., tensile strength, elongation, dimensions, freedom from holes)
- Chemical properties (e.g., powder residue if applicable, though these are powder-free)
- Biocompatibility (primary skin irritation in rabbits, delayed dermal contact sensitization in guinea pigs).
8. The sample size for the training set
- This question is not applicable as the device is not an AI/ML system and does not have a "training set."
9. How the ground truth for the training set was established
- This question is not applicable as the device is not an AI/ML system and does not have a "training set."
§ 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.