(54 days)
Powder Free Nitrile Examination Glove, Blue Color 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.
Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.
The provided text is for a 510(k) summary for "NON-CHLORINATED, POLYMER COATED, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE COLOR". This document describes the device and its compliance with established standards, but it does not contain information related to an AI/ML device. Therefore, many of the requested points regarding AI/ML device performance and testing (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.
Here's an analysis based on the information provided for the nitrile examination gloves:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM D 6319-00a and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Performance: Meets ASTM D 6319-00a | "Gloves meet all the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application." (Referring to ASTM D 6319-00a) |
| Pinhole/Leakage (21 CFR 800.20): Not explicitly stated but implied by ASTM compliance | Not explicitly detailed, but compliance with ASTM D 6319-00a would include limits on pinholes/water leakage. |
| Biocompatibility (Primary Skin Irritation): No irritation | "Primary skin irritation testing in the rabbit... indicate no irritation." |
| Biocompatibility (Delayed Contact Sensitization): No sensitization | "delayed contact sensitization testing in the guinea pig indicate no... sensitization." |
| Powder-Free Requirement: Absence of starch | "Final product is negative for the presence of starch using the USP iodine test." |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, number of animals for biocompatibility). The provenance of the data is that the tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., based in Malaysia. The studies were non-clinical (laboratory and animal-based) and are presented as retrospective data to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a non-AI/ML device submission for examination gloves. The "ground truth" is established by the specifications defined in ASTM D 6319-00a and 21 CFR 800.20, which are consensus standards and regulations.
4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are compared directly against established standard specifications.
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. 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. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:
- ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Application)
- 21 CFR 800.20 (Pinhole Barrier Integrity)
- USP iodine test (for absence of starch)
- Standard methods for biocompatibility testing (skin irritation and sensitization in animal models).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. 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.