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510(k) Data Aggregation
(94 days)
ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.
The provided document is a 510(k) summary for the ComfortPro Blue Nitrile Examination Gloves Powder Free. It describes the device, its intended use, and a comparison to a predicate device based on non-clinical performance data.
Here's the breakdown of the acceptance criteria and study information as requested:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|---|
| Bench Test Data | |||
| ASTM D6319-19 (Length) | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 250mm, Small: 241mm, Medium: 245mm, Large: 242mm, X-Large: 242mm |
| ASTM D6319-19 (Width) | To determine the width of the gloves | X-Small: 70+/-10 mm, Small: 80+/-10mm, Medium: 95+/-10 mm, Large: 110+/-10 mm, X Large: 120+/-10 mm | X-Small: 80 mm, Small: 82mm, Medium: 93mm, Large: 103mm, X-Large: 110mm |
| ASTM D6319-19 (Thickness) | To determine the thickness of the gloves | Palm: 0.05 mm min, Finger: 0.05 mm min (for all sizes) | Palm (mm): X-Small: 0.101, Small: 0.081, Medium: 0.091, Large: 0.092, X-Large: 0.091Finger (mm): X-Small: 0.121, Small: 0.097, Medium: 0.108, Large: 0.108, X-Large: 0.111 |
| ASTM D6319-19 (Tensile Strength) | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14 Mpa Min for all sizesAfter Ageing: Tensile Strength 14 Mpa Min for all sizes | Before Ageing (Mpa): X-Small: 27.2, Small: 23.2, Medium: 24, Large: 26.2, X-Large: 27.4After Ageing (Mpa): X-Small: 24.2, Small: 23.8, Medium: 27.6, Large: 27.6, X-Large: 27.9 |
| ASTM D6319-19 (Ultimate Elongation) | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizesAfter Ageing: Ultimate Elongation 400% Min for all sizes | Before Ageing (%): X-Small: 620, Small: 590, Medium: 570, Large: 570, X-Large: 550After Ageing (%): X-Small: 600, Small: 560, Medium: 540, Large: 540, X-Large: 550 |
| ASTM D5151-19 (Water Tight) | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Residual Powder) | To determine the residual powder in the gloves | ≤2 Mg/Glove | 0.49 mg/glove |
| Biocompatibility Data | |||
| ISO 10993-10:2010 (Primary Skin Irritation) | To evaluate the test item, for skin irritation test in New Zealand White rabbits. | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| ISO 10993-10:2010 (Dermal Sensitization) | To evaluate the test item, for the Skin Sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO10993-5:2009 (In vitro cytotoxicity) | To evaluate the test item, for its ability to induce cytotoxicity using L-929 mouse fibroblast cells by Elution Method. | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% test item extract and non-cytotoxic at 50%, 25%, 12.5% and 6.25% test item extracts. Moreover, under the conditions of the study, non acute systemic toxic. |
| ISO 10993-11:2017 (Acute Systemic Toxicity Test) | To evaluate the test item, for Acute Systemic Toxicity in Swiss Albino Mice. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the condition of study, the device extracts did not reveal any systemic toxicity. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, width, tensile strength, etc., or how many animals were used for biocompatibility tests). It only states they meet the relevant ASTM and ISO standards, which likely prescribe minimum sample sizes.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is "THAI RUBBER INDUSTRY COMPANY LIMITED" in Thailand, it is highly probable the testing was conducted in Thailand or by contractors on behalf of the Thai manufacturer. The nature of these tests (bench testing for physical properties and biocompatibility for materials) suggests they are prospective tests conducted on representative samples of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to this type of device (nitrile examination gloves) and the studies performed. The "ground truth" for these tests are objective, measurable physical and chemical properties and biological responses, determined by standardized test methods (ASTM, ISO), rather than expert interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving interpretation of medical images or patient outcomes where subjective expert opinion is involved. The tests for these gloves are objective measurements against predefined 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
- This question is not applicable. MRMC studies are specific to medical imaging devices, often involving AI, to assess the impact of AI assistance on human reader performance. Examination gloves do not involve "readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This concept applies to AI-driven algorithms. The ComfortPro Blue Nitrile Examination Gloves are physical medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the defined specifications and test methods within the ASTM and ISO standards. For example, the "ground truth" for length is "Min 230 mm," and the test result is a direct measurement. Similarly, for biocompatibility, the "ground truth" is "not an irritant" or "non-cytotoxic," determined by specific biological assays.
- It's a combination of objective measurements compared against pre-defined normative standards.
8. The sample size for the training set
- This question is not applicable. The device is not an AI/ML algorithm that requires a "training set." The performance data is derived from testing physical samples of the manufactured gloves.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
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(125 days)
Comfortpro latex examination powder free gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
COMFORTPRO Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free.
This is a 510(k) summary for a medical device, specifically, a latex examination glove. The document describes the device's characteristics and compares them against a predicate device and established performance standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate) | Device Performance (Current) | Comparison |
|---|---|---|---|---|
| Dimensions - Length | ASTM D3578-19 | Min 230 mm for all sizes | Overall: Length > 230 mm X-Small: 245 mm Small: 238 mm Medium: 233 mm Large: 240 mm | Similar |
| Dimensions - Width (Medium size) | ASTM D3578-19 | Min 95 +/- 10 mm (for medium size) | Overall: Min 95+/-10 mm (for medium size) X-Small: 77 mm Small: 81 mm Medium: 93 mm Large: 101 mm | Similar |
| Physical Properties - Tensile Strength | ASTM D3578-19 | Before Ageing: Tensile Strength > 18 MPa After Ageing: Tensile Strength > 14 MPa | Before Ageing: Tensile Strength > 18 MPa Actual values: X-Small: 29.6 MPa, Small: 25 MPa, Medium: 26 MPa, Large: 24.9 MPa After Ageing: Tensile Strength > 14 MPa Actual values: X-Small: 25.5 MPa, Small: 24.1 MPa, Medium: 22.2 MPa, Large: 24.4 MPa | Similar |
| Physical Properties - Ultimate Elongation | ASTM D3578-19 | Before Ageing: Ultimate Elongation > 650% After Ageing: Ultimate Elongation > 500% | Before Ageing: Ultimate Elongation > 650% Actual values: X-Small: 810%, Small: 760%, Medium: 680%, Large: 780% After Ageing: Ultimate Elongation > 500% Actual values: X-Small: 820%, Small: 760%, Medium: 650%, Large: 760% | Similar |
| Thickness | ASTM D3578-19 | Palm: > 0.08 mm Finger: > 0.08 mm | Palm: > 0.08 mm Actual values: X-Small: 0.102 mm, Small: 0.087 mm, Medium: 0.10 mm, Large: 0.108 mm Finger: > 0.08 mm Actual values: X-Small: 0.114 mm, Small: 0.109 mm, Medium: 0.122 mm, Large: 0.121 mm | Similar |
| Powder Free Residue | ASTM D3578-19 | $\leq$ 2 mg/glove | 0.68 mg/glove (for Medium) | Similar |
| Water Tight (1000 ml) | ASTM D5151-19 AQL-2.5 | Passes | Passes | Similar |
| Extractable Protein | ASTM D5712-15 | 200 µg/dm² Max | 187.1 µg/dm² (for Medium) | Meets criteria |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Under the condition of study, not an irritant | Under the condition of study, not an irritant | Same |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% (neat) test item extract. A follow-up acute systemic toxicity test demonstrated the extract did not present an acute systemic toxicity concern. | Meets criteria |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017(E) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length or tensile strength). However, the tests are conducted according to ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15, which describe the standard test methods and typically include specifications for sampling.
The data provenance is from non-clinical bench testing and biocompatibility studies of the "Comfortpro" device. The manufacturer is THAI RUBBER INDUSTRY COMPANY LIMITED, located in Thailand. The tests are therefore likely performed by the manufacturer or a third-party lab on behalf of the manufacturer, and the data is prospective as it's generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination glove) does not involve a "ground truth" established by human experts in the typical sense of medical image analysis or diagnostic studies. The performance is assessed against established international consensus standards (ASTM and ISO) for physical properties and biocompatibility. The "ground truth" is not based on expert interpretation but on the quantitative measurement and qualitative assessment defined by these standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the performance is measured against objective standards, not subjective human assessment requiring adjudication.
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 not an AI-powered diagnostic device or a device where human interpretation is a primary performance factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by international consensus standards (ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15, ISO 10993-10:2010(E), ISO 10993-5:2009(E), ISO 10993-11:2017(E)). These standards specify the test methods and the acceptable ranges for the physical and biological properties of the gloves.
8. The Sample Size for the Training Set
Not applicable. 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
Not applicable. There is no training set for this type of device.
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