(111 days)
This Surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
MAXITEX NEURO PF, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D3577-01a2.
The device described in the 510(k) summary is the MAXITEX NEURO PF (Sterile surgical glove, Powderfree). It is a surgical glove, and its performance is evaluated against established industry standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3577-01a2 (Surgical Gloves) | Meets the requirements for surgical gloves. |
| ASTM D412 (Rubber Properties in Tension) | Test indicates the product meets the requirements. |
| ASTM D5712 (Protein Content) | Contains less than 50 micrograms/gram of water extractable protein. |
| ASTM F719-81 (Primary Skin Irritation) | Indicates no sensitization or irritation. |
| ASTM F720-81 (Dermal Sensitization) | Indicates no sensitization or irritation. |
| FDA requirements | Meets FDA requirements. |
| Labeling claims | Meets labeling claims. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size for each performance test. The tests are general compliance tests for the product type.
- Data Provenance: Not explicitly stated, but the submission is from Terang Nusa Sdn Bhd, a company in Malaysia. The tests refer to ASTM standards, which are international.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the performance of these surgical gloves is established by compliance with the referenced ASTM standards, which define acceptable physical properties and biological responses. These are objective performance measures, not subjective interpretations by experts in the context of ground truth for AI/diagnosis.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation is based on objective measurements and comparison to predefined thresholds in the ASTM standards, not subjective adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not applicable as the device is a surgical glove, not an AI or diagnostic tool that involves human readers interpreting cases.
6. Standalone Performance Study
- Standalone Performance Study Done: Yes, in the sense that the device's technical specifications and physical properties were tested in isolation against the ASTM standards. The "Brief description of non-clinical tests" highlights these tests conducted per ASTM D3577-01ae2, ASTM D 412, and ASTM D5712.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth is primarily based on predetermined performance standards and specifications outlined in ASTM (American Society for Testing and Materials) standards. This includes physical properties (e.g., tensile strength from ASTM D412), protein content (ASTM D5712), and biocompatibility/irritation tests (ASTM F719-81, ASTM F720-81).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. Surgical glove manufacturing and testing do not involve a "training set" in the context of machine learning or AI models. The manufacturing process is designed to consistently produce gloves meeting the specifications, and samples are taken for quality control and compliance testing.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in this context. The manufacturing processes and quality control systems are designed to ensure adherence to the established ASTM standards and internal specifications.
§ 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).