(228 days)
The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves:
This document is a 510(k) summary for a medical device (examination gloves). As such, the "acceptance criteria" and "study" described are for the device itself and its physical properties and biocompatibility, not for an AI algorithm. Therefore, many of the questions related to AI-specific study design (like MRMC, standalone AI performance, training sets, expert qualifications for ground truth in AI) are not applicable.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM 6319-00a) | Reported Device Performance (Powder-Free Nitrile Examination Gloves) |
|---|---|---|
| Detection of Holes (ASTM 5151) | Multiple Normal G1, AQL = 2.5 | Pass G1 AQL = 2.5* |
| Length (mm) | ||
| - Size XS | Min 220 | 240 mm minimum for all sizes* |
| - Size S | Min 220 | |
| - Size M | Min 230 | |
| - Size L | Min 230 | |
| - Size XL | Min 230 | |
| Palm Width (mm) | ||
| - Size XS | 70 ± 10 | 73-78* |
| - Size S | 80 ± 10 | 83-88* |
| - Size M | 95 ± 10 | 93-98* |
| - Size L | 111 ± 10 | 103-107* |
| - Size XL | 120 ± 10 | 110-118* |
| Thickness (mm) | ||
| - Finger | Min 0.05 | Min 0.06* |
| - Palm | Min 0.05 | Min 0.05* |
| Physical Properties - Before Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 15 - 21* |
| - Ultimate Elongation (%) | Min 500 | 550 - 630* |
| Physical Properties - After Aging | ||
| - Tensile Strength (Mpa) | Min 14 | 14 - 22* |
| - Ultimate Elongation (%) | Min 400 | 520 - 610* |
| Powder Content | Max 2.0 mg/glove | Below 2.0 mg/glove* |
| Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) | PII ≥ 5.0 indicates an irritate (irritant threshold) | PII was "0.04"* |
| Dermal Sensitization Test (ISO 10993-10) | Score ≥ 1 indicates irritation/hypersensitivity (sensitizer threshold) | Score was "0"* |
* Indicates data points explicitly marked with an asterisk in the source document, referencing "Third Party test data is available in Appendix A" or "Amendment F" (for biocompatibility).
Study Details (Applicable to Device Performance)
2. Sample size used for the test set and the data provenance
The document provides acceptance criteria from ASTM D6319-00a and CPSC/ISO standards. It states that the device "meets the ASTM D6319-00a Standard" and "meets... CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements."
- Test Sets: The document refers to various ASTM test methods (D5151 for holes, D412/D573 for tensile properties, D6124-06 for powder content) and specific biocompatibility tests (CPSC Title 16 Chapter II Part 1500 for Primary Skin Irritation and ISO 10993-10 for Dermal Sensitization).
- Sample Sizes: The exact sample sizes for each specific test (e.g., how many gloves were tested for holes, how many animals for biocompatibility) are not explicitly specified in this summary document. It only provides the performance results.
- Data Provenance: The document states "Third Party test data is available in Appendix A" for the general performance tests and "Third Party test data is available in Amendment F" for biocompatibility. The biocompatibility tests were completed by "Mediamal Testing and Consultancy Services." The country of origin for the data is not specified beyond originating from this third-party testing entity. The studies are prospective in nature, as they involve actively testing new device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" here is established by standardized physical and chemical tests (e.g., measuring glove dimensions, tensile strength, chemical content, biological reactions) rather than expert interpretation of complex data (like medical images). The "experts" would be the technicians and scientists performing the ASTM, CPSC, and ISO standardized tests, ensuring they follow the protocols correctly. Their qualifications are inherent in the accreditation of the third-party testing facility.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements or standardized biological assays, not subjective assessments requiring adjudication among multiple human readers.
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 a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established by:
- Standardized Physical Measurements: Length, width, thickness, tensile strength, elongation are objective physical properties measured according to ASTM standards.
- Chemical Analysis: Powder content is determined by a chemical analysis method (ASTM D6124-06).
- Standardized Biological Assays: Primary Skin Irritation and Dermal Sensitization tests are conducted according to CPSC and ISO standards on biological models (animal testing as implied by the standards for such biocompatibility tests). The "ground truth" for irritation/sensitization is based on observing specific, quantified biological responses compared to established thresholds.
8. The sample size for the training set
Not applicable. There is no AI model or algorithm that requires a "training set" for these examination gloves. The device is evaluated based on its inherent physical and chemical properties.
9. How the ground truth for the training set was established
Not applicable, as no training set exists for this type of 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.