(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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.