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510(k) Data Aggregation
(58 days)
TC Gloves Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
TC Gloves Powder Free Latex Examination Gloves is a Class I device bearing the product code LYY (21CFR 880.6250). They meet all the current specifications listed under the ASTM D3578 - 19, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. These gloves are white in color having Finger Texture / Ambidextrous and are powder free. The product is non-sterile.
This document is a 510(k) Premarket Notification for a medical device: "TC Gloves Powder Free Latex Examination Gloves." As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with performance standards for the gloves, not an AI/algorithm-based diagnostic device. The request asks about AI-related aspects (e.g., number of experts, MRMC studies, training set), which are not applicable to the clearance of examination gloves.
Therefore, the response will focus on the performance criteria for the gloves as outlined in the document.
Acceptance Criteria and Device Performance for "TC Gloves Powder Free Latex Examination Gloves"
The acceptance criteria for the "TC Gloves Powder Free Latex Examination Gloves" are based on recognized standards for medical gloves, primarily ASTM D3578-19 and ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15 for performance, and ISO 10993-1:2018 for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Proposed Device Actual Data | Result |
|---|---|---|---|
| Dimensions | ASTM D3578-19 | ||
| Length | 230 mm min (all sizes) | 240.3mm - 240.9mm (all sizes) | Pass |
| Width (S) | 80 mm ± 10 | 85mm | Pass |
| Width (M) | 95 mm ± 10 | 95.8mm | Pass |
| Width (L) | 111 mm ± 10 | 104.5mm | Pass |
| Width (XL) | 120 mm ± 10 | 113.5mm | Pass |
| Thickness (Palm) | 0.08 mm min (all sizes) | 0.13mm - 0.14mm (all sizes) | Pass |
| Thickness (Finger) | 0.08 mm min (all sizes) | 0.15mm (all sizes) | Pass |
| Physical Property (ASTM D3578-19) | |||
| Tensile Strength (Before Aging) | 18 Mpa Min (all sizes) | 19.8 Mpa - 20.0 Mpa | Pass |
| Tensile Strength (After Aging) | 14 Mpa Min (all sizes) | 19.2 Mpa - 19.4 Mpa | Pass |
| Ultimate Elongation (Before Aging) | 650% Min (all sizes) | 800.9% - 805.5% | Pass |
| Ultimate Elongation (After Aging) | 500% Min (all sizes) | 790.5% - 794.9% | Pass |
| Barrier Property (ASTM D5151-19) | |||
| Detection of Holes | AQL 2.5 | AQL 2.5 | Pass |
| Powder-Free Residue (ASTM D6124-06) | |||
| Residual Powder Content | ≤ 2 mg/Glove Max (all sizes) | 0.31 mg - 0.57 mg | Pass |
| Extractable Protein (ASTM D5712-15) | |||
| Extractable Protein Content | 200 µg/dm² max (all sizes) | 34.82 µg/dm² - 50.0 µg/dm² | Pass |
| Biocompatibility (ISO 10993-1:2018) | |||
| Invitro Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin Sensitization | Not a sensitizer | Not a sensitizer | Pass |
| Skin Irritation | Not an irritant | Not an irritant | Pass |
| Acute Systemic Toxicity | Device extracts do not pose a systemic toxicity. | Device extracts do not pose a systemic toxicity. | Pass |
| Material-Mediated Pyrogenicity | Device did not demonstrate a material-mediated Pyrogenicity response. | Device did not demonstrate a material-mediated Pyrogenicity response. | Pass |
2. Sample size used for the test set and the data provenance:
The document summarizes the results but does not specify the exact sample sizes (number of gloves) for each test. The tests were conducted according to the referenced ASTM and ISO standards, which typically specify sampling plans.
The data provenance is from the manufacturer, Thanh Cong Pharmaceutical and Trading Company Limited, located in Bac Ninh province, Vietnam. The tests are "Non-Clinical Data," implying laboratory testing of the product. The document does not specify if the testing was retrospective or prospective in relation to the submission date, but it represents data collected specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. This is not an AI/algorithm-based diagnostic device. The "ground truth" for glove performance is established by the specified ASTM and ISO standards, which define the testing methodologies and acceptance criteria. Experts in materials testing and quality control would perform and interpret these tests, but a panel of "experts" to establish "ground truth" in the way it's used for AI validation is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not for an AI/algorithm-based diagnostic device requiring human 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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on established, quantitative, and objective international and national standards for medical device performance, specifically for examination gloves. This includes:
- ASTM International Standards: These define specific methodologies for testing physical properties (dimensions, tensile strength, elongation), barrier properties (detection of holes), chemical properties (powder residue, extractable protein).
- ISO International Standards (e.g., ISO 10993-1): These define methodologies for evaluating the biological safety (biocompatibility) of medical devices.
The "ground truth" is defined by the objective measurements obtained through these standardized tests compared against the predefined quantitative acceptance limits within those standards.
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of medical device clearance.
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(52 days)
TC Gloves- Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
TC Gloves- Powder Free Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous, Single use and are powder free. The product is non-sterile. Sizes available - S, M, L and XL.
The provided document is a 510(k) Summary for TC Gloves - Powder Free Nitrile Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance proof for a novel AI/software medical device. Therefore, the requested information, which is highly specific to the acceptance criteria and study design for AI-based medical devices, cannot be fully extracted from this document.
However, I can provide the acceptance criteria and reported device performance for the physical and biological characteristics of the gloves as detailed in the document, which serves as the "acceptance criteria" against which the device's performance is measured for this type of medical device (physical examination gloves).
Here's an attempt to answer the questions based on the provided document, acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
For a physical medical device like examination gloves, the "acceptance criteria" are defined by relevant ASTM standards and the "performance" is the actual test data.
| SI No. | Test Performed & Acceptance Criteria (ASTM D6319-19 unless specified) | Reported Device Performance (Actual Data) |
|---|---|---|
| Dimension | ||
| 1. | Length: 230mm min (all sizes) | S: 241.4 mm, M: 240.6 mm, L: 243.2 mm, XL: 242.7 mm |
| Width: S: 80 mm±10, M: 95 mm ±10, L: 110 mm ±10, XL: 120 mm ±10 | S: 86.6 mm, M: 96.5 mm, L: 106.4 mm, XL: 113.8 mm | |
| Thickness (Palm): 0.05 mm min (all sizes) | S: 0.14 mm, M: 0.14 mm, L: 0.14 mm, XL: 0.13 mm | |
| Thickness (Finger): 0.05 mm min (all sizes) | S: 0.16 mm, M: 0.15 mm, L: 0.15 mm, XL: 0.16 mm | |
| Physical Property | ||
| 2. | Tensile Strength (Before Aging): 14 MPa Min for all sizes | S: 15.7 MPa, M: 15.5 MPa, L: 15.4 MPa, XL: 15.2 MPa |
| Tensile Strength (After Aging): 14 MPa Min for all sizes | S: 15.0 MPa, M: 15.3 MPa, L: 14.9 MPa, XL: 15.3 MPa | |
| Ultimate Elongation (Before Aging): 500% Min for all sizes | S: 515.8%, M: 514%, L: 512%, XL: 511.2% | |
| Ultimate Elongation (After Aging): 400% Min for all sizes | S: 469.2%, M: 510%, L: 510%, XL: 468.9% | |
| Barrier Property | ||
| 3. | Detection of Holes (ASTM D6319-19 / ASTM D5151-19): Passes AQL 2.5 | S: AQL 2.5, M: AQL 2.5, L: AQL 2.5, XL: AQL 2.5 |
| Powder Free Residue | ||
| 4. | Residual Powder Content (ASTM D6124-06): ≤2 mg/Glove Max | S: 0.41 mg, M: 0.23 mg, L: 0.57 mg, XL: 0.37 mg |
| Biocompatibility | ||
| 1. | In Vitro Cytotoxicity (ISO 10993-1:2018): Under the conditions of the study, not cytotoxic. | Under the conditions of the study, cytotoxic to L-929 cells. Additional Testing was performed to determine if this was a systemic toxicity concern. |
| 2. | Skin Sensitization (ISO 10993-1:2018): Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. (Pass) |
| 3. | Skin Irritation (ISO 10993-1:2018): Under the condition of study not an irritant. | Under the condition of study not an irritant. (Pass) |
| 4. | Acute Systemic Toxicity (ISO 10993-1:2018): Under the conditions of the study, the device extracts do not pose a systemic toxicity concern. | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern. (Pass) |
| 5. | Material Mediated Pyrogenicity (ISO 10993-1:2018): Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response. (Pass) |
2. Sample size 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 of the performance tests (Dimension, Physical Property, Detection of Holes, Powder Free Residue, Biocompatibility). The testing is standard for manufacturing quality control of examination gloves and would typically involve sampling from production batches.
- Sample Size: Not specified in the document.
- Data Provenance: The tests were conducted by the manufacturer, Thanh Cong Pharmaceutical And Trading Company Limited, located in Bac Ninh province, Vietnam. The tests are non-clinical, likely prospective (testing newly manufactured gloves), and carried out to demonstrate compliance with ASTM standards.
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 is not applicable to the evaluation of medical examination gloves. The "ground truth" for the performance of these gloves is established through physical and chemical testing against recognized national and international standards (e.g., ASTM, ISO), not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept (adjudication for ground truth establishment) is relevant for clinical studies, particularly in image interpretation or diagnostic performance, not for the physical and chemical testing of medical gloves.
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 physical medical device (examination gloves), not an AI/software device. No MRMC study was performed as it is not relevant to the device's function or regulatory requirements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. The "performance" is inherent to the glove's material properties and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is the defined specifications within universally recognized standards like ASTM D6319-19 and ISO 10993-1:2018. Compliance with these physical, chemical, and biological properties serves as the benchmark for safety and effectiveness for examination gloves.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "ground truth for a training set." The regulatory pathway for this device relies on demonstrated compliance with established performance standards and substantial equivalence to a predicate device.
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