(111 days)
Powder Free Synthetic Rubber Latex (BarrierPro™) 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.
CleantexxTM Powder Free Synthetic Rubber Latex Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierProTM synthetic rubber latex, a polybutadiene based copolymer. They are natural white in color and are powder free.
Here's a breakdown of the acceptance criteria and study information for the Cleantexx™ Powder Free Synthetic Rubber Latex Examination Gloves, based on the provided 510(k) summary:
This device is not an AI/ML powered medical device, therefore, many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Physical Properties: | |
| ASTM D 6319-00a | Meets all current ASTM D 6319-00a specifications |
| Biocompatibility: | |
| Primary skin irritation (USP ) | No irritation |
| Delayed contact sensitization (ISO 10993) | No sensitization |
| Powder-Free Status: | |
| Presence of starch (USP iodine test) | Negative for starch |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided summary. The summary indicates "Testing performed per ASTM D 6319 - 00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig." The specific number of gloves/animals tested for each of these would be detailed in the full test reports, which are not included here.
- Data Provenance: The manufacturing company is LATEXX MANUFACTURING SDN. BHD. based in Malaysia. The testing would have been conducted by them or a contracted laboratory. The summary does not specify the country of origin of the data beyond the manufacturer's location. The studies are non-clinical (laboratory and animal-based) rather than human observational (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is an examination device (gloves) and not an AI/ML or diagnostic device that requires expert ground truth for interpretation of results. The "ground truth" here is defined by meeting specified engineering and biological safety standards (e.g., ASTM standards, USP tests), which are evaluated through objective laboratory measurements and animal studies, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/ML or diagnostic device, there is no need for adjudication of results by experts. The tests performed are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm or AI component is involved in this device.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is based on:
- Standard Specifications: Meeting the performance requirements outlined in ASTM D 6319-00a, which defines physical properties for examination gloves.
- Biocompatibility Standards: Absence of primary skin irritation and delayed contact sensitization, assessed through established animal testing protocols (e.g., USP for irritation, ISO 10993 for sensitization guidance).
- Chemical Purity Standards: Negative result for the presence of starch via the USP iodine test, demonstrating the "powder-free" claim.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore, no training set for an algorithm was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set was used, no ground truth needed to be established for it.
§ 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.