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510(k) Data Aggregation
(107 days)
Vinyl Exam Gloves 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.
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided document describes the acceptance criteria and a study proving the substantial equivalence of Vinyl Exam Gloves (K213019) to a predicate device. This is a 510(k) submission, focusing on non-clinical performance testing rather than clinical trials.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | Magnusson and Kligman grade shall be less than control group; No significant reaction than the control group | No skin irritation (Under the conditions of the study, not an Irritant) |
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | (Implicitly same as irritation, often evaluated together - document states "Magnusson and Kligman grade shall be less than control group") | No skin sensitization (Under the conditions of the study, not a Sensitization) |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | The viability shall be not reduced to less than 70% | No cytotoxic (Under the conditions of the study, the device is non-cytotoxic) |
| Residual Powder (ASTM D6124-06 (Reapproved 2017)) | Less than 2.0mg per glove | Less than 2.0mg |
| Freedom from Holes (ASTM D5151-06 (Reapproved 2015)) | Do not show droplet, stream, or other type of water leakage | No leakage |
| Physical Dimensions - Length (ASTM D6319-10 (Reapproved 2015)) | > 230 mm | Larger than 230mm |
| Physical Dimensions - Width (ASTM D6319-10 (Reapproved 2015)) | XS = 75±5mm, S = 85±5mm, M = 95±5mm, L = 105±5mm, XL = 115±5mm | XS: within 75±5mm, S: within 85±5mm, M: within 95±5mm, L: within 105±5mm, XL: within 115±5mm |
| (Note: Table 1 uses ASTM D5250-19 and lists width for XL as 105±5mm, but Table 2 uses D6319-10 and lists width for XL as 115±5mm. Assuming D6319-10 is the primary for this test type in T2 and the data aligns with it). | ||
| Physical Dimensions - Thickness (Finger & Palm) (ASTM D6319-10 (Reapproved 2015)) | All Sizes ≥ 0.08 mm | Larger than 0.08mm |
| Physical Properties - Tensile Strength (Before Aging) (ASTM 412-16) | 11MPa min | Larger than 11Mpa |
| Physical Properties - Ultimate Elongation (Before Aging) (ASTM 412-16) | 300% min | Larger than 300% |
| Physical Properties - Tensile Strength (After Aging) (ASTM 412-16) | 11MPa min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
| Physical Properties - Ultimate Elongation (After Aging) (ASTM 412-16) | 300% min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, dimensions, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for specific tests beyond what is implicit in the standard (e.g., ASTM standards typically define sample sizes).
- Data Provenance (Country of Origin): Not explicitly stated, though the manufacturer (Hebei Astro Medical Supply Co., Ltd) is based in China. The testing labs are not identified.
- Retrospective or Prospective: This distinction is not applicable to non-clinical bench testing. These are controlled performance tests conducted on representative samples of the manufactured device.
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 information is not applicable to this type of submission. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) which define objective, measurable physical and biocompatibility properties. There are no human experts establishing a subjective "ground truth" for these tests in the same way, for instance, a radiologist would read an X-ray. The "experts" are the lab technicians and scientists performing the standardized tests according to defined protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation studies where there is subjective assessment by multiple human readers. For standardized non-clinical performance and biocompatibility tests, the results are objectively measured against established 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. MRMC studies are specific to AI/CAD systems that assist human readers in interpreting medical images. This submission is for medical gloves, which do not involve human interpretation of images or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (ASTM D5250-19, ASTM D5151-19, ASTM D3767-03 (2020), ASTM D412-16, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, ISO 10993-5:2009, ASTM D6319-10). These standards provide objective, measurable parameters for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and biological safety (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device that requires a training set.
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