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510(k) Data Aggregation
(150 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
Powder-Free Vinyl Examination Glove
The provided documentation describes the acceptance criteria and a study demonstrating that the Cartagloves S.A. Powder-Free Vinyl Examination Glove meets these criteria, supporting its substantial equivalence claim.
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance (Applicant Device Specification) |
|---|---|---|
| Dimensions | Meets ASTM D 5250-06 | |
| Width (Small) | 85 mm | 85 +/- 5 mm |
| Width (Medium) | 95 mm | 95 +/- 5 mm |
| Width (Large) | 105 mm | 105 +/- 5 mm |
| Width (X-Large) | 115 mm | 115 +/- 5 mm |
| Length (all sizes) | 230 mm minimum | 250 +/- 10 mm |
| Thickness (Finger) | 0.05 mm minimum | 0.05 mm minimum |
| Thickness (Palm) | 0.08 mm minimum | 0.1 mm minimum |
| Physical Properties | Meets ASTM D 5250-06 | |
| Tensile Strength (Before Aging) | 9 MPa minimum | 9 MPa minimum |
| Tensile Strength (After Aging) | 9 MPa minimum | 9 MPa minimum |
| Ultimate Elongation (Before Aging) | 300% minimum | 300% minimum |
| Ultimate Elongation (After Aging) | 300% minimum | 300% minimum |
| Freedom from Pinholes | Meets ASTM D 5250-06 and ASTM D 5151-99 | AQL 2.5, Level I (Water Leak Test) |
| Powder Free | Meets ASTM D 6124-06 and ASTM D 5250-06 | Adheres to standard requirements |
| Biocompatibility | Based on ISO 10993 | |
| Cytotoxicity - Agar Diffusion | N/A (Standard for "Passed") | Passed |
| Primary Skin Irritation | N/A (Standard for "Passed") | Passed |
| Repeated Patch Dermal Sensitization | N/A (Standard for "Passed") | Passed |
2. Sample size used for the test set and the data provenance
The documentation does not explicitly state the specific "sample size" for each test (e.g., number of gloves tested for dimensions, physical properties, or pinholes). However, it implies that the testing was conducted according to the sampling plans outlined within ASTM D5250, ASTM D5151, and ASTM D6124, which typically include specific AQL (Acceptable Quality Level) and inspection levels for quality control.
The data provenance is not explicitly stated in terms of country of origin but is from the applicant, Cartagloves S.A., located in Cartagena, Colombia. The testing appears to be internal to the manufacturer or conducted by a designated lab on their behalf. The data is presented as retrospective performance data collected to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this device. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards (ASTM and ISO), not subjective expert interpretation of images or clinical data. There is no concept of "ground truth" established by experts in the context of these types of engineering and material performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation (e.g., medical image reading) requires consensus among multiple evaluators. For the performance testing of examination gloves, the measurements are objective (e.g., tensile strength, dimensions, pinhole count) and determined by standardized test procedures, 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
This question is not applicable to this device. An MRMC study with AI assistance is relevant for diagnostic devices that analyze medical images or data. The Cartagloves S.A. device is an examination glove, which is a physical barrier device, and does not involve human readers or AI in its intended use or performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. "Standalone performance" typically refers to the performance of an AI algorithm or an automated diagnostic system operating without human interaction. This is not relevant for a physical medical device like an examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the examination glove is defined by adherence to published and accepted industry standards:
- ASTM D 5250-06 ("Standard Specification for Poly(vinyl chloride) Gloves for Medical Application")
- ASTM D 5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993 (Biological evaluation of medical devices)
The device's performance against these quantifiable criteria (e.g., specific dimensions, tensile strength values, AQL levels for pinholes) constitutes the "ground truth" for its safety and effectiveness relative to the specified standards.
8. The sample size for the training set
This question is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The Cartagloves S.A. device is an examination glove, and its manufacturing and testing do not involve machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable to this device, as there is no "training set" in the context of examination glove manufacturing and testing.
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