(98 days)
The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Medical Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The provided document is a 510(k) summary for Medical Examination Gloves. It details the device's characteristics and compares them to a predicate device to demonstrate substantial equivalence. Since this is an application for a Class I medical device (Medical Examination Gloves), the acceptance criteria and supporting studies are focused on demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device, rather than a detailed AI-driven diagnostic or treatment device study. Therefore, many of the requested categories for AI/human reader studies are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (from recognized standards) and Reported Device Performance:
| Acceptance Criteria (from Standards) | Proposed Device Performance | Predicate Device Performance (per submitted document) |
|---|---|---|
| Dimensions (ASTM D6319-19) | ||
| Length, mm (min) | S: 220, M: 230, L: 230, XL: 230 | 230 |
| Width, mm (tolerance) | S: 80 ($\pm 10$), M: 95 ($\pm 10$), L: 110 ($\pm 10$), XL: 120 ($\pm 10$) | XS: 75 ($\pm 5$), S: 85 ($\pm 5$), M: 95 ($\pm 5$), L: 105 ($\pm 5$), XL: 115 ($\pm 5$) |
| Finger Thickness, mm (min) | 0.05 | 0.05 |
| Palm Thickness, mm (min) | 0.05 | 0.05 |
| Note: "Analysis1" states that the proposed device's dimensions meet ASTM D6319-19, despite differences from the predicate. | ||
| Physical Properties (ASTM D6319) | ||
| Before Aging Tensile Strength (min) | 14 MPa | 14 MPa |
| Before Aging Ultimate Elongation (min) | 500% | 500% |
| After Aging Tensile Strength (min) | 14 MPa | 14 MPa |
| After Aging Ultimate Elongation (min) | 400% | 400% |
| Freedom from Holes (ASTM D5151) | AQL=2.5 | AQL=2.5 |
| Powder Content (ASTM D6124) | 0.15 | "Meet the requirements of ASTM D6124" |
| Biocompatibility (ISO 10993-10, -5, -11) | ||
| Irritation (ISO 10993-10) | Not an irritant | Comply with ISO10993-10 |
| Sensitization (ISO 10993-10) | Not a sensitizer | (Not explicitly stated for predicate, but overall compliance implies) |
| Cytotoxicity (ISO 10993-5) | Potentially cytotoxic | Comply with ISO10993-5 |
| Systemic Toxicity (ISO 10993-11) | Does not elicit a systemic toxicity response | Complies with ISO 10993-11 Third edition 2017-09 |
| Material | Nitrile | Nitrile |
| Powdered/Powder-free | Powdered free | Powdered free |
Study Proving Device Meets Acceptance Criteria:
The device's compliance is proven through a series of non-clinical (bench) tests against recognized international and national standards. The document explicitly states:
- "The following tests were performed to evaluate the biocompatibility of the proposed device, the tests' results to show substantial equivalence to the predicate device:"
- ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
- "In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:"
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification For Medical Examination Gloves For Medical Application.
- ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each non-clinical test (e.g., number of gloves tested for holes, number of samples for biocompatibility). These are typically determined by the testing standards themselves.
The data provenance is from testing conducted by the manufacturer (Guangdong Gymda Medical Technology Co., Ltd) or their designated testing facilities in China, as indicated by the company's address and the origin of the submission. These are prospective tests conducted during the device development and submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For this type of device (medical examination gloves), the "ground truth" for performance is established by the specified standards (ASTM, ISO) and laboratory testing methodologies, not by expert human interpretation of results in the way a diagnostic AI system would require. The tests yield objective, measurable outcomes (e.g., tensile strength, presence of holes, cytotoxicity levels).
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in human interpretation of data, typically for clinical studies or image-based diagnostic systems. The non-clinical tests performed here produce direct, quantifiable results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study is not applicable. The device is a physical barrier (glove).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth is based on objective measurements against established performance specifications and biocompatibility endpoints defined by international and national standards (ASTM and ISO), measured through laboratory testing.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning system that requires a training set. The "training" for such devices involves adherence to manufacturing quality systems and design controls to consistently produce devices meeting specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no "training set" in the context of an AI model 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.