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510(k) Data Aggregation
(114 days)
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This document describes the performance testing for a medical device: "Nitrile Patient Examination Glove" (K222527). The tests demonstrate that the device meets established acceptance criteria, primarily through non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | Grades less than 1, otherwise sensitization. |
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | Viability reduced to <70% of the blank indicates cytotoxic potential. |
| Residual Powder Content (ASTM D6124-06 (Reapproved 2017)) | Powder residue limit of 2.0 mg/glove. |
| Freedom from Holes (ASTM D5151-06 (Reapproved 2015)) | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. |
| Dimensions (ASTM D6319-10 (Reapproved 2015)) | Length: S $\ge$ 220 mm; M, L, XL $\ge$ 230 mm. Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Thickness (mm): Finger $\ge$ 0.05; Palm $\ge$ 0.05. |
| Physical Properties - Before Aging (ASTM D6319-10) | Tensile strength: $\ge$ 14 MPa. Ultimate Elongation: $\ge$ 500%. |
| Physical Properties - After Accelerated Aging (ASTM D6319-10) | Tensile strength: $\ge$ 14 MPa. Ultimate Elongation: $\ge$ 400%. |
2. Sample sizes used for the test set and the data provenance
- Freedom from Holes: 125 gloves were tested.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity), Powder Content, Dimensions, Physical Properties: The document does not specify the exact sample size for each of these tests, but it indicates that tests were performed according to the referenced ASTM and ISO standards, which typically include specific sampling plans. For instance, ASTM D6319 for dimensions requires a certain number of gloves per lot for testing.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter's address is in China and the nature of the device (examination gloves), it is likely that the testing was conducted by or on behalf of the manufacturer, presumably in adherence to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes technical and biological performance testing for medical gloves, not an AI or imaging device that requires expert human interpretation for ground truth. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for diagnostic accuracy in a test set. The "ground truth" for these tests is defined by the objective measurements obtained through standardized laboratory procedures (e.g., tensile strength, dimensions, chemical analysis, in vitro/in vivo biocompatibility assays).
4. Adjudication method for the test set
Not applicable. As noted above, this device did not involve human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative measurements against predefined criteria.
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 not an AI/imaging device, therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device, therefore, no standalone algorithm performance testing was conducted.
7. The type of ground truth used
The ground truth used for these tests is based on:
- Physical Measurements: Objective measurements of dimensions (length, width, thickness), tensile strength, and elongation according to ASTM standards.
- Chemical Analysis: Quantitative measurement of residual powder content.
- Biological Assays: Standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization on animals) biological tests using established protocols (ISO 10993 standards) where the "ground truth" is the observed biological response compared to predefined thresholds.
- Defect Detection: Water leakage test for freedom from holes.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set in the AI context. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training and validation paradigm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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