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510(k) Data Aggregation
(95 days)
The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text describes the acceptance criteria and a study for Disposable Vinyl Examination Gloves. It is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Physical Properties | ||
| Tensile Strength (Before Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (Before Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Tensile Strength (After Aging) | 11 MPa, min (per ASTM D5250) | Meets 11 MPa, min |
| Ultimate Elongation (After Aging) | 300% min (per ASTM D5250) | Meets 300% min |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Meets the requirements (AQL=2.5) |
| Powder Content | <0.04 mg per glove (Meets the requirements of ASTM D6124) | Meets the requirements (<0.04 mg per glove) |
| Dimensions | ||
| Length (XS, S, M, L, XL) | 220mm (XS, S), 230mm (M, L, XL) min (Tolerance specified: min) | 220mm (XS, S), 230mm (M, L, XL) min |
| Width (XS, S, M, L, XL) | 70mm (XS), 80mm (S), 90mm (M), 100mm (L), 110mm (XL) (Tolerance: ±5) | 70mm (XS), 80mm (S), 90mm (M), 100mm (L), 110mm (XL) |
| Finger Thickness | 0.05 mm min | 0.05 mm min |
| Palm Thickness | 0.08 mm min | 0.08 mm min |
| Biocompatibility | ||
| Irritation | Not an irritant (Compliant with ISO 10993-10) | Under the conditions of the study, not an irritant. Complies with ISO 10993-10. |
| Sensitization | Not a sensitizer (Compliant with ISO 10993-10) | Under conditions of the study, not a sensitizer. Complies with ISO 10993-10. |
| Cytotoxicity | No potential toxicity to L-929 cells (Compliant with ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells. Complies with ISO 10993-5. |
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement |
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 explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom from Holes or how many samples for Biocompatibility). It refers to compliance with standards like ASTM D5151, ASTM D6124, ISO 10993-10, and ISO 10993-5, which would have their own specified sampling plans.
The manufacturer is Shandong Zhushi Pharmaceutical Group Co., Ltd located in Shandong, China. The tests were conducted to demonstrate compliance with international standards, but specific data provenance within China is not detailed. The tests are non-clinical and would be considered prospective as they were performed to verify that the proposed device met design specifications before market approval.
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 is not applicable as the device is a vinyl examination glove and the "ground truth" is established through adherence to recognized international and national standards for physical properties, chemical properties, and biocompatibility, not by expert consensus on interpretations of medical images or complex diagnostic assessments. The "ground truth" is objective measurement against specified criteria.
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 typically used for establishing ground truth in subjective assessments like medical image interpretation. For a physical medical device like gloves, the assessment is based on objective measurements and compliance with established standards, not 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
Not applicable. This device is a disposable vinyl examination glove, not an AI-powered diagnostic tool. MRMC studies are used for evaluating the effectiveness of AI in assisting human readers in diagnostic tasks.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the acceptance criteria is defined by recognized international and national standards (e.g., ASTM D5250 for physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder content, and ISO 10993-5/10 for biocompatibility). Test results are compared directly against the specifications outlined in these standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for such a device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, this question is irrelevant.
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