(253 days)
A Sterile Nitrile Surgical Gloves Powder Free is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Nitrile Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of synthetic rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type II - gloves compounded from synthetic rubber latex. The proposed device is Sterile Nitrile Surgical Gloves Powder Free, and is produced in sizes 6, 6 ½, 7, 7 ½, 8, 8 ½, and 9. All sizes share the same White color. The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10-6 while packaged to maintain sterility. The shelf life is 3 years.
The provided text describes the acceptance criteria and the results from non-clinical performance testing for a medical device, "Sterile Nitrile Surgical Gloves Powder Free." It does not contain information about studies involving human readers or AI assistance. Therefore, I will focus on the non-clinical performance testing detailed.
Here's the information extracted and organized as requested, with "N/A" for sections not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (AC) | Reported Device Performance (Result) | Met AC |
|---|---|---|---|---|
| ASTM D5151-2019 | Freedom from holes (Before aging) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D5151-2019 | Freedom from holes (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D5151-2019 | Freedom from holes (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | AQL 1.5 (3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (Before aging) | Minimum 17MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Minimum 12MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Tensile strength (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Minimum 12MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate Elongation (Before aging) | Minimum 650% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate elongation (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Minimum 490% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Ultimate elongation (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Minimum 490% for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (Before accelerated aging) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Stress at 500% elongation (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | Maximum 7.0MPa for all sizes (AQL 4%, 3 non-consecutive lots) | Pass | Yes |
| ASTM F1929, Test Method for detecting seal leaks in porous medical packaging by dye penetration | Package integrity (After accelerated aging: 70 ± 2°C for 166 ± 2 h) | No penetration (AQL 0.65%, 3 non-consecutive lots) | Pass | Yes |
| ASTM F1929, Test Method for detecting seal leaks in porous medical packaging by dye penetration | Package integrity (After accelerated aging: 50 ± 2°C for 90 ± 1 days) | No penetration (AQL 0.65%, 3 non-consecutive lots) | Pass | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine the length of the gloves | Min 265mm for all sizes | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine the width of the gloves | Specific width ranges for each size (e.g., 76±6mm for Size 6) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine finger thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine palm thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | To determine cuff thickness | Minimum 0.10mm for all sizes (AQL 4%) | Pass for all sizes listed | Yes |
| ASTM D6124-06R17, Standard Test Method for Residual Powder on Medical Gloves | Less than 2mg/glove | Maximum 2mg/glove for all sizes | Pass | Yes |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Irritation | Under the conditions of the testing, not an irritant | Pass | Yes |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization | Sensitization | Under the conditions of the testing, not a sensitizer | Pass | Yes |
| ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in-vitro Cytotoxicity | Cytotoxicity | Under the conditions of the testing, non-cytotoxic | Pass | Yes |
| ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests | Acute systemic toxicity | Under the conditions of the testing, no acute systemic toxicity | Pass | Yes |
| USP 41 Pyrogen Test | Material mediated pyrogenicity | Under the conditions of the testing, non-pyrogenic | Pass | Yes |
| USP 42 Bacterial Endotoxin Test | Bacterial endotoxin limits | Less than 20EU/glove | Pass | Yes |
2. Sample size used for the test set and the data provenance
The document refers to "3 non-consecutive lots" for AQL (Acceptable Quality Limit) testing in several instances. However, the specific number of gloves sampled from each lot for each test is not explicitly stated.
Data provenance: Not specified (origin of the gloves/materials for testing). This is a non-clinical device performance test, not a study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This submission concerns non-clinical performance testing of a physical medical device (gloves), not a diagnostic algorithm requiring expert "ground truth." The "ground truth" here is established by standardized test methods and their defined pass/fail criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See point 3.
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
N/A - This is not an AI/algorithm-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/algorithm device. Standalone performance is demonstrated by the physical and biological testing results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standard for these tests is defined by the technical specifications and methodologies outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-19 for surgical gloves, ISO 10993 for biological evaluation). These standards prescribe the testing procedures and define acceptable limits for various physical, chemical, and biological properties.
8. The sample size for the training set
N/A - This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
N/A - See point 8.
§ 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).