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510(k) Data Aggregation
(128 days)
The Titan powder free nitrile patient examination glove, blue color, 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. It has blue color and is sold as non sterile.
Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
Device: Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans)
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Standard) | Reported Device Performance (Brand Name: Titans) |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets ASTM D 6319-10 (Published 03/18/2011) |
| Physical Property | ASTM D 6319-10 | Meets ASTM D 6319-10 (Published 03/18/2011) |
| Free of Pinhole | ASTM D5151 (AQL 2.5) | Meets ASTM D5151 (AQL 2.5) (Published 08/20/2012) |
| Residue Powder | ASTM D6124 | Meets ASTM D6124 (Published 08/20/2012) |
| Primary Skin Irritation | ISO 10993-10: 2010 | Not a primary skin irritant under the conditions of the study |
| Dermal Sensitization | ISO 10993-10: 2010 | Not a dermal sensitizer under the conditions of the study |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the individual tests (e.g., for pinhole detection, physical properties, or biocompatibility). It only indicates that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." The data provenance (country of origin, retrospective/prospective) and specific sample sizes for these tests are not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a patient examination glove, and the testing involves adherence to established ASTM and ISO standards for physical properties, performance, and biocompatibility. Ground truth in this context is defined by the objective measurements and pass/fail criteria of these standards, not by expert interpretation or consensus on images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective measurements against consensus standards, an adjudication method for reconciling expert opinions is not necessary or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist them. For patient examination gloves, the evaluation centers around predetermined physical, chemical, and biological performance standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (gloves), not an algorithm or AI. Performance is assessed through standardized laboratory tests, not by an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on established consensus standards (ASTM D6319-10, ASTM D5151, ASTM D6124, ISO 10993-10) with specific, objective pass/fail criteria for dimensions, physical properties, absence of pinholes, residue powder levels, and biocompatibility endpoints (skin irritation and sensitization).
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured product (gloves), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm or training set, this question is not relevant to the described device.
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