(119 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 Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non-Colored). Non-Sterile" device:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-06 | |
| ASTM D 6319-10 | Meets | |
| Powder Free Residue | ASTM D 6124-06 | |
| ASTM D 6319-10 | Meets | |
| Biocompatibility: | ||
| Dermal Sensitization | ISO 10993-10:2010 | Not a contact skin sensitizer |
| Primary Skin Irritation | 16 CFR Part 1500 | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Biocompatibility). It only states that the device "meets" the referenced ASTM and ISO standards. These standards themselves would define the required sample sizes for their respective tests.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that Kossan Latex Industries is a Malaysian company and they are claiming compliance with international standards, it's highly probable the testing was conducted by or overseen by the manufacturer, potentially in Malaysia or by certified testing labs. The document implies these are prospective tests conducted to demonstrate compliance for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against objective, measurable, and standardized technical specifications (ASTM, ISO, CFR standards). Ground truth, in the sense of expert consensus, is typically relevant for interpretative tasks, such as diagnostic imaging analysis or clinical assessments, which is not the case for this product.
4. Adjudication Method for the Test Set
This is not applicable. The performance evaluations are based on direct measurement and laboratory testing against pre-defined, quantitative standards, not on subjective interpretations requiring adjudication.
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 is not applicable. This submission is for a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable for the same reasons as point 5. There is no algorithm involved with this device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the objective measurement and testing results against the established quantitative criteria defined in the referenced standards (ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10:2010, and 16 CFR Part 1500). For example:
- Dimensions: Measured directly against the specified ranges in ASTM D 6319-10.
- Physical Properties: Tensile strength, elongation, etc., measured according to methods outlined in ASTM D 6319-10.
- Freedom from pin-holes: Water leak test (ASTM D 5151-06) or air leak test methods.
- Powder Free Residue: Measured gravimetrically as per ASTM D 6124-06.
- Biocompatibility: Standardized biological assays (dermal sensitization, primary skin irritation) with predefined endpoints for "not a sensitizer" or "not an irritant."
8. The Sample Size for the Training Set
This is not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI. Performance is based on physical testing of manufactured samples.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
§ 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.