(70 days)
The Vinyl Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
The provided document describes a 510(k) premarket notification for a Vinyl Examination Glove (Clear, Non-Colored). This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices. The document explicitly states that clinical testing is not needed for this device (Page 7, Section 9). This means the study described is a non-clinical study focused on meeting established performance standards for examination gloves, rather than a clinical trial involving human patients or complex algorithms.
Therefore, many of the requested elements for describing a study that proves device acceptance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, training set sample size, ground truth for training set) are not applicable in this context.
Below is the information that can be extracted or inferred from the provided text regarding acceptance criteria and the non-clinical study that demonstrates the device meets these criteria.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / ASTM Requirement) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|
| Physical Properties | ||
| Tensile Strength Before Aging: 15 MPa, min | 15 MPa, min | SAME as predicate, complies with ASTM D5250 |
| Ultimate Elongation Before Aging: 380 % min | 380 % min | SAME as predicate, complies with ASTM D5250 |
| Tensile Strength After Aging: 15 MPa, min | 15 MPa, min | SAME as predicate, complies with ASTM D5250 |
| Ultimate Elongation After Aging: 380 % min | 380 % min | SAME as predicate, complies with ASTM D5250 |
| Freedom from Holes (per ASTM D5151, AQL=1.5) | Be free from holes | SAME as predicate |
| Powder Content (limit) | 0.5 mg (meets requirements of ASTM 5250) | SIMILAR to predicate (which states "Meet the requirements of ASTM 5250"), implies compliance |
| Dimensions (per ASTM D5250) | ||
| Length, mm (all sizes S, M, L, XL): min 230-245 | S: 230, M: 235, L: 245, XL: 245 | SAME as predicate |
| Width, mm (all sizes S, M, L, XL): ±5 | S: 85, M: 95, L: 105, XL: 115 | SAME as predicate |
| Thickness, mm: Finger: min 0.05 | 0.05 | SAME as predicate |
| Thickness, mm: Palm: min 0.08 | 0.08 | SAME as predicate |
| Biocompatibility (per ISO 10993-10, ISO 10993-5) | ||
| Irritation | Not an irritant | SIMILAR to predicate, complies with ISO 10993-10 |
| Sensitization | Not a sensitizer | SIMILAR to predicate, complies with ISO 10993-10 |
| Cytotoxicity | Did not show potential toxicity to L-929 cells | SIMILAR to predicate, complies with ISO 10993-5 |
| Labeling | ||
| Meet FDA's Requirements | Meets FDA's Requirements | SAME as predicate |
Non-Clinical Study Information
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample size for each test. However, standards like ASTM D5151 (Freedom from Holes) and ISO 2859-1 (Sampling Procedures for Inspection by Attributes) imply specific sampling methodologies and statistical sample sizes are used for these types of tests on manufacturing lots. For example, AQL=1.5 for freedom from holes suggests a defined sampling plan from a batch of gloves.
- Data Provenance: The tests were conducted to verify design specifications and compliance with international standards (ISO, ASTM). The manufacturer is Huifu Trading Co., Ltd. in China. The tests are non-clinical, meaning they involve laboratory or bench testing of the physical device, not human subjects. It's a type of prospective testing against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a non-clinical study for a Class I medical device (patient examination glove). "Ground truth" in the sense of expert consensus for medical interpretation or diagnosis is not relevant here. The "ground truth" is defined by established international and national standards (ASTM, ISO) for physical properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in clinical studies or studies involving human assessment of data. For non-clinical tests on physical devices, the outcome is determined by adherence to specified test protocols and objective measurements against predefined acceptance limits in the 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
- Not Applicable. This device is a vinyl examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related comparative effectiveness are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device has no algorithmic component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by objective, quantitative specifications defined in international and national standards, such as:
- ASTM D5250: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- ISO 2859-1: Sampling Procedures for Inspection by Attributes.
8. The sample size for the training set
- Not Applicable. This is not a study involving machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is irrelevant.
§ 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.