(117 days)
The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are made of natural rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have yellow color.
This document describes the premarket notification for Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine). The study proves the device meets the acceptance criteria by demonstrating its compliance with various ASTM standards and ISO 10993-10 for physical, biocompatibility, and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Standard) | Reported Device Performance (Titanfine) |
|---|---|---|
| Dimension | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Physical Property | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Free of Pinhole | Meets ASTM D5151 (AQL 1.5) | Meets ASTM D5151 (AQL 1.5) |
| Residue Powder | Meets ASTM D6124 | Meets ASTM D6124 |
| Water Soluble Protein | Meets ASTM D5712-10 | Meets ASTM D5712-10 (Limit: 200 µg/dm²) |
| Primary Skin Irritation | ISO 10993-10: 2010 | Not a primary skin irritant |
| Dermal Sensitization | ISO 10993-10: 2010 | Not a dermal sensitizer |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test or the specific data provenance (e.g., country of origin, retrospective or prospective nature) for the testing. It generally states that "Tests were conducted following the recommended procedures outlined in the respective consensus standards."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on compliance with established technical standards (ASTM and ISO), not expert consensus in a diagnostic sense.
4. Adjudication method for the test set
Not applicable. The test results are pass/fail based on meeting the specified criteria of the referenced standards.
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 a medical device (surgical gloves), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (surgical gloves), not an algorithmic device.
7. The type of ground truth used
The ground truth used for demonstrating compliance is based on established industry standards and physical/chemical testing results. Specifically:
- Physical properties and dimensions: ASTM D3577-09
- Freedom from pinholes: ASTM D5151 (AQL 1.5)
- Residual powder: ASTM D6124
- Water-soluble protein: ASTM D5712-10
- Biocompatibility (primary skin irritation and dermal sensitization): ISO 10993-10: 2010
8. The sample size for the training set
Not applicable. This is a medical device (surgical gloves), not an AI/machine learning device that requires a training set. The "training" in this context refers to the manufacturing process ensuring consistency with quality standards.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning device, there is no "training set ground truth" in that sense. The manufacturing process is designed to produce gloves consistently meeting the established standards.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).