(42 days)
This Non-Sterile, Powder-Free, Black Nitrile 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.
Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.
The acceptance criteria and device performance for the Non-Sterile, Powder-Free, Black Nitrile Examination Gloves are detailed below, based on the provided document K061553.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (ASTM D6319-00a) | Reported Device Performance (Powder Free Nitrile Examination Gloves) |
|---|---|---|
| Watertight (1000ml) | Multiple Normal GII, AQL = 2.5 | Pass GII, AQL = 2.5 |
| Length (mm) | Min 220 (XS, S), Min 230 (M, L) | 240 mm minimum for all sizes |
| Palm width (mm) | XS: 70 ± 10, S: 80 ± 10, M: 95 ± 10, L: 111 ± 10 | XS: 73-78, S: 83-88, M: 93-98, L: 103-107 |
| Thickness (mm) | Finger: Min 0.05, Palm: Min 0.05 | Finger: Min 0.08, Palm: Min 0.08 |
| Physical Properties (Before Aging) | Tensile Strength: Min 14 MPa, Ultimate Elongation: Min 500% | Tensile Strength: 15-21 MPa, Ultimate Elongation: 550-630% |
| Physical Properties (After Aging) | Tensile Strength: Min 14 MPa, Ultimate Elongation: Min 400% | Tensile Strength: 14-22 MPa, Ultimate Elongation: 520-610% |
| Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the exact sample size used for each individual test (e.g., number of gloves tested for watertightness, length, etc.). However, for the watertight test, it references "Multiple Normal GII" with an AQL (Acceptable Quality Level) of 2.5, which implies a statistically determined sample size based on lot size, as per ASTM standards for inspection.
- Data Provenance: The document does not specify the country of origin of the data. It is presented as summary performance data based on ASTM D6319-00a and FDA 1000ML watertight tests conducted by the manufacturer, YTY Industry (Manjung) Sdn Bhd, located in Malaysia. The nature of these tests (dimensional, physical property, chemical testing) suggests they are laboratory-based tests rather than human subject data, thus the terms "retrospective or prospective" are not directly applicable in the biological or clinical sense but rather describe the execution of a standardized test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a medical glove, and the "ground truth" for its performance is established through adherence to standardized physical and chemical specifications, not through expert clinical interpretation. The performance data is objective and measurable against the ASTM D6319-00a standard. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The "tests" are objective measurements against a standard, not 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:
Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is the objective measurements and specifications defined by the ASTM D6319-00a standard for nitrile examination gloves. These include physical properties (length, width, thickness, tensile strength, elongation) and chemical properties (powder content), as well as a watertightness test.
8. The sample size for the training set:
Not applicable. This device is a physical product, a medical glove, and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this 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.