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510(k) Data Aggregation
(90 days)
The nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided text describes the regulatory filing for Nitrile Examination Gloves and includes non-clinical testing results. It does not involve a medical device with an AI algorithm, a diagnostic purpose, or human-in-the-loop performance. Therefore, many of the requested fields are not applicable.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length: S: ≥220mm; M/L/XL: ≥230mm | Length: >230mm / Pass |
| Width: S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm | Width: S: 83-85mm / Pass; M: 94-96mm / Pass; L: 110-112mm / Pass; XL: 113-117mm / Pass | ||
| Thickness: Finger: ≥0.05mm; Palm: ≥0.05mm | Thickness: Finger: 0.12-0.15mm / Pass; Palm: 0.08-0.10mm / Pass | ||
| ASTM D5151 | Watertightness (Holes) | Meet the requirements of ASTM D5151 AQL 2.5 | 0/200 / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.1-0.3mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 17-38MPa / Pass; Ultimate Elongation: 501-565% / Pass |
| Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 18-43MPa / Pass; Ultimate Elongation: 500-564% / Pass | |
| ISO 10993-5 | Cytotoxicity | Under conditions of the study, device extract is cytotoxic (Note: The table entries are a bit confusing here, but the result suggests it was acceptable). | Reported result for ISO 10993-5 is "Under conditions of the study, device extract is cytotoxic" (This appears to be an acceptance criteria statement, not a 'Pass' for the device itself. A positive for cytotoxicity is usually undesirable, implying here it was within an acceptable range or a specific interpretation of the standard criteria. For similar devices, non-cytotoxicity is often the goal. However, without further context for their specific criteria, it's presented as stated in the table). |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant / Pass |
| ISO 10993-10 | Sensitization | Under conditions of the study, not a sensitizer | Under conditions of the study, not a sensitizer / Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For the Watertightness test (ASTM D5151), a sample size of 200 was used.
- Other tests (dimensions, powder content, physical properties, biocompatibility) do not explicitly state the sample size in the provided document, but typically these standards specify minimum sample numbers.
- Data Provenance: The tests were conducted to verify that the proposed device met all design specifications. The document implies these were laboratory tests performed for the manufacturer, Shanxi Nacosa Medical Technology Co.,Ltd, which is located in China. The data would be prospective in nature, as it's generated specifically for the 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 device is a physical medical glove, not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" here is established by standardized testing methods and their inherent measurement criteria. Therefore, not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is laboratory testing against established standards, not interpretation by experts.
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 or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the acceptance criteria specified in recognized international and national standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series). The device's performance is measured against these numerical and qualitative benchmarks.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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