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510(k) Data Aggregation
(253 days)
Sterile Nitrile Surgical Gloves Powder Free
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.
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(108 days)
Sterile Nitrile Surgical Gloves, Powder-free
The powder-free Nitrile Surgical Gloves, is a sterile and single use devise made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.
The subject device is a surgical nitrile qlove made of synthetic nitrile latex compound. It is sterile, powder-free. The device is anatomic. The device meets ASTM D 3577-09: Standard specification for Rubber Surgical gloves for Medical Application. The device is for over-the counter single use.
This document describes the performance data and acceptance criteria for the "Sterile Nitrile Surgical Gloves, Powder-free" manufactured by Primus Gloves Pvt. Limited (K170515).
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Test Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from Pinholes | FDA 1000 ml water leak test, ASTM D5151-06 (reap 2011), ISO 2859-1 / G1/AQL 2.5 | PASS |
| Dimensions - Length | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 265 mm | PASS (> 265 mm) |
| Dimensions - Width | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, 76±6 mm to 114±6 mm (sizes 6 to 9) | PASS (76±6 mm to 114±6 mm) |
| Dimensions - Thickness | ASTM D 3577-09, ISO 2859-1 / S2/AQL 4.0, > 0.10 mm (Cuff, palm & finger) | PASS (> 0.10 mm) |
| Physical properties - Before aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 17 Mpa, Ultimate Elongation: > 650 %, Stress at 500% Elongation | PASS (> 17 Mpa, > 650 %) |
| Physical properties - After Accelerated aging | ASTM D 3577-09 and ASTM D412-06, ISO 2859-1 / S2/AQL 4.0, Tensile strength: > 12 Mpa, Ultimate Elongation: > 490 % | PASS (> 12 Mpa, > 490 %) |
| Powder-free residue | ASTM D 3577-09 and ASTM D6124-06, N=5, Less than 2 mg per glove | PASS (Less than 2 mg per glove) |
| Biocompatibility - Primary skin irritation | ISO 10993-10, Not an irritant | PASS (Not an irritant) |
| Biocompatibility - Skin/Dermal Sensitization | ISO 10993-10, Not a sensitizer | PASS (Not a sensitizer) |
| Sterility | ISO 11737-02, Sterile (SAL of 10^-6 achieved) | Pass (SAL of 10^-6 achieved) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Sampling plan/Inspection level/AQL" for some tests:
- Freedom from Pinholes: G1/AQL 2.5 (per ISO 2859-1)
- Dimensions: S2/AQL 4.0 (per ISO 2859-1)
- Physical properties (Before and After aging): S2/AQL 4.0 (per ISO 2859-1)
- Powder-free residue: N=5
The specific total sample sizes (number of gloves tested) for each characteristic are not explicitly stated as a single number but are derived from the specified AQL (Acceptance Quality Limit) and inspection levels per ISO 2859-1.
Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the testing labs are located) or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This document describes the testing of a medical device (surgical gloves) against recognized consensus standards (ASTM, ISO, FDA). The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by these standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements (e.g., dimensions, tensile strength, leak test) against defined numerical or qualitative standards. There is no mention of, nor a need for, human adjudication for these types of tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact on human reader performance. The device here is a physical product (surgical gloves).
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the studies conducted are standalone performance studies of the device itself, without human-in-the-loop performance. The various physical, chemical, and biological tests assess the inherent properties and performance of the glove.
7. The Type of Ground Truth Used:
The "ground truth" used for these studies is based on:
- Consensus Standards: Specifically ASTM D 3577-09, ASTM D412-06, ASTM D5151-06 (reap 2011), ASTM D6124-06, ISO 2859-1, ISO 10993-10, and ISO 11737-02.
- Defined Pass/Fail Criteria: Each test has numerical or qualitative criteria for what constitutes a "PASS" (e.g., tensile strength > 17 Mpa, less than 2 mg powder per glove, not an irritant).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (surgical gloves) and does not involve AI/machine learning algorithms that require a "training set" in the context of image analysis or diagnostic models. The manufacturing process itself (which is optimized over time) could be considered a form of "training," but not in the data science sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI/ML for this device. The quality control and manufacturing processes ensure the product consistently meets the established standards.
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