(52 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Patient Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-11 & ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-11 & ASTM D 6319-10 | Meets |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization (as per ISO 10993-10:2010) | Not a contact skin sensitizer |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation Test (as per 16 CFR Part 1500) | Not a primary skin irritant |
| Sterility | Non-Sterile (inherent characteristic) | Non-Sterile |
| Single Use | Yes (inherent characteristic) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document (K123760) does not specify the sample size used for the test set for any of the performance characteristics. It only states that the device "Meets" the standards or passes the biocompatibility tests.
The data provenance is not explicitly stated as "country of origin" for the specific test data, but the submitter is based in Malaysia. The testing refers to international and US-based standards (ASTM, ISO, CFR), implying these tests were conducted according to those guidelines, potentially by an accredited lab. The study is retrospective in the sense that the test data was collected prior to this submission, but it's not a clinical study involving patients over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards, not through clinical expert review or diagnosis of medical images/conditions. The "ground truth" for this type of device is defined by the technical specifications outlined in the ASTM, ISO, and CFR standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective assessments, often by human readers (e.g., radiologists interpreting images). The performance of these gloves is assessed objectively against quantifiable standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (gloves) and its conformity to technical standards.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on established industry standards and regulatory criteria. These involve:
- Physical Specifications: ASTM D6319-10 for dimensions and physical properties.
- Freedom from Defects: ASTM D5151-11 and D6319-10 for pin-holes.
- Chemical Properties: ASTM D6124-11 and D6319-10 for powder-free residue.
- Biocompatibility: ISO 10993-10:2010 for dermal sensitization and 16 CFR Part 1500 for primary skin irritation.
These standards define the acceptable range or limits for each characteristic.
8. The Sample Size for the Training Set
This information is not applicable. This submission concerns a physical medical device and its conformity to standards. There is no AI or machine learning "training set" involved in its evaluation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation, as described in point 7, is established by industry and regulatory bodies through the development and publication of the relevant standards.
§ 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.