(97 days)
Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
The provided document, a 510(k) Premarket Notification from the FDA, describes the acceptance criteria and performance of a medical device: Latex Examination Powder Free Gloves.
This document is NOT related to an AI/ML device, a comparative effectiveness study, or a study involving human readers or expert ground truth adjudication. Therefore, many of the requested details, such as sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided text for this specific device.
Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves
The study described here focuses on demonstrating the substantial equivalence of the "Latex Examination Powder Free Gloves" to legally marketed predicate devices by showing that they meet established performance standards (primarily ASTM and ISO standards for medical gloves) and are as safe and effective.
1. A table of acceptance criteria and the reported device performance
| Characteristic / Test Method | Acceptance Criteria | Reported Device Performance for Subject Device (K213073) |
|---|---|---|
| Dimensions - Length (ASTM D3578-19) | Min 230 mm for all sizes | X-Small: 245 mm |
| Small: 244 mm | ||
| Medium: 247 mm | ||
| Large: 240 mm | ||
| X-Large: 247 mm | ||
| Dimensions - Width (ASTM D3578-19) | X-Small: 70+/-10 mm | |
| Small: 80+/-10 mm | ||
| Medium: 95+/-10 mm | ||
| Large: 111+/-10 mm | ||
| X Large: 120+/-10 mm | X-Small: 77 mm | |
| Small: 80 mm | ||
| Medium: 92 mm | ||
| Large: 101 mm | ||
| X-Large: 110 mm | ||
| Thickness (ASTM D3578-19) | Palm: 0.08 mm min for all sizes | |
| Finger: 0.08 mm min for all sizes | Palm: | |
| X-Small: 0.115 mm, Small: 0.115 mm, Medium: 0.115 mm, Large: 0.121 mm, X-Large: 0.109 mm | ||
| Finger: | ||
| X-Small: 0.125 mm, Small: 0.128 mm, Medium: 0.132 mm, Large: 0.135 mm, X-Large: 0.122 mm | ||
| Physical Properties - Tensile Strength (Before Ageing) (ASTM D3578-19) | 18 MPa Min for all sizes | X-Small: 26.2 MPa |
| Small: 25.0 MPa | ||
| Medium: 24.0 MPa | ||
| Large: 22.6 MPa | ||
| X-Large: 24.2 MPa | ||
| Physical Properties - Tensile Strength (After Ageing) (ASTM D3578-19) | 14 MPa Min for all sizes | X-Small: 24.1 MPa |
| Small: 24.1 MPa | ||
| Medium: 23.4 MPa | ||
| Large: 24.3 MPa | ||
| X-Large: 22.5 MPa | ||
| Physical Properties - Ultimate Elongation (Before Ageing) (ASTM D3578-19) | 650% Min for all sizes | X-Small: 830% |
| Small: 790% | ||
| Medium: 810% | ||
| Large: 800% | ||
| X-Large: 800% | ||
| Physical Properties - Ultimate Elongation (After Ageing) (ASTM D3578-19) | 500% Min for all sizes | X-Small: 800% |
| Small: 760% | ||
| Medium: 830% | ||
| Large: 810% | ||
| X-Large: 780% | ||
| Water Tight (Detection of Holes) (ASTM D5151-19) | AQL 2.5 | Passes AQL 2.5 |
| Powder Free Residue (ASTM D6124-06) | $\le$ 2 mg/glove | X-Small: 0.60 mg/glove |
| Small: 0.80 mg/glove | ||
| Medium: 1.46 mg/glove | ||
| Large: 0.62 mg/glove | ||
| X-Large: 1.13 mg/glove | ||
| Aqueous Extractable Protein (ASTM D5712-15) | 200 $\mu$g/ dm² Max | Medium: 191.9 $\mu$g/ dm² |
| 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 |
| 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 |
| Biocompatibility - In Vitro Cytotoxicity (ISO10993-5:2009(E)) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study the device is "cytotoxic". (Note: The document states this is similar to the reference device and expected for latex as it's a "positive control" for this test, implying it's a known property of natural latex and deemed acceptable for the intended use of the glove). |
| Biocompatibility - Acute Systemic Toxicity Test (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 did not reveal any systemic toxicity. |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for length, width, etc.). It refers to meeting the standards (ASTM/ISO), which typically outline sampling plans.
The data provenance is based on bench tests conducted on the subject device, "Latex Examination Powder Free Gloves". The tests are non-clinical. The submitting company is THAI RUBBER GLOVES CO., LTD., located in THAILAND. Therefore, the data originates from tests performed by or for this manufacturer. The nature of the tests (bench tests, not patient data) means the retrospective/prospective distinction is not directly applicable in the same way it would be for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device or a diagnostic study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for glove performance is defined by adherence to established industry standards and specifications (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a diagnostic study with human-interpreted results, no adjudication method was used.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by adherence to established international and national standards and specifications for latex examination gloves, such as ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15, ISO 10993-10, ISO 10993-5, and ISO 10993-11. These standards define the acceptable physical, mechanical, and biological properties of the gloves.
8. The sample size for the training set
Not applicable. This is not a machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this device.
§ 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.