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510(k) Data Aggregation
(84 days)
The Disposable Nitrile 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 patient examination gloves. The subject device is blue color and has 5 models of XS,S, M, L, XL. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
The provided text describes the acceptance criteria and the results of non-clinical testing for a medical device, specifically a "Disposable Nitrile Examination Glove." It does not contain information about studies involving AI, human readers, or clinical trials.
Here's a breakdown of the requested information based on the provided text, focusing on the available non-clinical data:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):XS/S: ≥220;M/L/XL: ≥230;Width:XS: 70±10;S: 80±10;M: 95±10;L: 105±10;XL: 115±10Thickness (mm):Finger: ≥0.05Palm: ≥0.05 | Length (mm): >230Width (mm):XS: 72-74;S: 80-83M: 95-98L: 110-114XL: 118-121PassThickness (mm):XS (Finger: 0.07-0.10, Palm: 0.08-0.10)S (Finger: 0.08-0.11, Palm: 0.08-0.11)M (Finger: 0.08-0.12, Palm: 0.07-0.11)L (Finger: 0.08-0.12, Palm: 0.08-0.11)XL (Finger: 0.08-0.12, Palm: 0.08-0.12)Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 2/125 leaksS: 0/125 leaksM: 0/125 leaksL: 1/125 leaksXL: 0/125 leaksPass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS: 0.05mgS: 0.06mgM: 0.06mgL: 0.07mgXL: 0.09mgPass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength:XS: 15.4-17.3S: 15.3-16.9M: 15.4-17.3L: 15.4-17.6XL: 15.3-17.1PassUltimate Elongation:XS: 524-569S: 525-568M: 525-567L: 527-566XL: 520-570Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Results for "After Aging" for Tensile Strength and Ultimate Elongation are specified in the acceptance criteria, but specific numerical performance results are not explicitly provided in the "Results" column of the table. However, since there is a "Pass" next to the "ultimate Elongation" line, it can be inferred that these too met the criteria. |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells.Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant.Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer.Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Watertightness (ASTM D5151): 125 gloves were tested for each size (XS, S, M, L, XL).
- Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): The document does not specify the exact sample sizes for these tests, but it indicates that tests were performed for each glove size (XS, S, M, L, XL).
- Data Provenance: The tests were conducted to demonstrate compliance with international (ISO) and US (ASTM) standards. The manufacturer is based in China. The data's specific origin beyond that is not detailed in the provided text, and it appears to be prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable. The study described is a non-clinical device testing study, relying on standardized test methods (ASTM, ISO) rather than expert interpretation of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not present in this non-clinical testing. The adherence to standard methodologies (e.g., AQL for ASTM D5151) implies a defined pass/fail criterion rather than expert 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 section is Not Applicable. The provided document describes non-clinical testing of a physical medical device (examination gloves) and does not involve AI, human readers, or comparative effectiveness studies of that nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. The device is a physical examination glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the defined parameters and measurement techniques of the referenced international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). For example, for "Watertightness," the ground truth is a quantitative measurement of leaks based on ASTM D5151 and an AQL of 2.5. For "Cytotoxicity," it's the observed cellular response in an in-vitro test according to ISO 10993-5.
8. The sample size for the training set
This section is Not Applicable. The provided document describes non-clinical performance testing of a manufactured product, not machine learning model development. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is Not Applicable for the same reason as point 8.
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