(85 days)
A Vinyl patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.
The provided text describes a 510(k) premarket notification for "Vinyl Examination Gloves, Powdered." This is a medical device submission, but it outlines the equivalence of the gloves to a legally marketed predicate device rather than detailing an AI/ML-based diagnostic system. As such, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not applicable to this type of submission for a physical medical device like gloves.
However, I can extract the acceptance criteria and how the device (gloves) is shown to meet them based on the information provided.
Acceptance Criteria and Device Performance (Vinyl Examination Gloves)
This submission focuses on demonstrating substantial equivalence to a predicate device, specifically "Class I vinyl patient examination gloves 80LYZ, powdered, that meets all the requirements of ASTM D 5250-00." The acceptance criteria for the new device are directly linked to meeting the requirements of this ASTM standard and other specified tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/How it's Met |
|---|---|---|
| Material Equivalence | Chemical composition of the glove material. | Listed chemical components (PVC resin, DOP, TXIB, Epoxidized Soyabean Oil, Ca/Zn carboxylate stabilizer) are presumably equivalent to those used in the predicate device meeting ASTM D 5250-00. Details are not provided in the summary but are implied to be part of the full submission. |
| Physical Properties | Size specifications and various physical properties as defined by ASTM D 5250-00. | "Please refer to attached sheet.(SPECIFICATION OF POWDERED VINYL EXAMINATION GLOVFS, APRIL 30, 2002)" This indicates that the device meets the physical property requirements of ASTM D 5250-00, which includes tensile strength, elongation, and dimensions. |
| Barrier Integrity (Pin Hole) | FDA 1000ml water leak test, with specific sampling procedure and acceptance quality level (AQL). | The device is subjected to the "FDA 1000ml water leak test" with a specified sampling procedure and AQL. The implication is that the device passes this test to the required AQL, demonstrating barrier integrity equivalent to the predicate. |
| Classification | Meet Class I vinyl patient examination gloves 80LYZ as per regulatory classification. | The device is identified as "Class I vinyl patient examination gloves 80LYZ, powdered," matching the classification of the predicate device. |
Regarding the study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is primarily a bench-testing and materials characterization study, as is typical for non-software/AI medical devices like examination gloves. The submission is a demonstration of substantial equivalence to an existing predicate device based on adherence to recognized standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document explicitly mentions "Sampling procedure and acceptance quality level" for the Pin Hole test. While the exact number of gloves tested is not provided in this summary, it would be determined by the specific "sampling procedure" and "acceptance quality level" (AQL) outlined for the FDA 1000ml water leak test. These AQL tables specify the sample sizes required to make an inference about the quality of a lot.
- Data Provenance: The studies were conducted by "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD." which is located in "LUANNAN, TANGSHAN CITY, HEBEI PROVINCE, CHINA." This indicates the data originated from China, likely from internal company testing. The data would be prospective in the sense that the manufacturer tested their produced gloves to ensure they meet the 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)
- Not Applicable. For a physical product like examination gloves, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic accuracy are not relevant. The "ground truth" here is adherence to specified physical and material properties, which are measured objectively using standardized laboratory tests by qualified quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, particularly in diagnostic imaging or clinical trials. For objective physical and chemical tests (e.g., measuring tensile strength, performing a water leak test), the results are quantitative and do not typically require expert adjudication in this manner. Standard laboratory practices for quality control and verification would be followed.
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 product (gloves), not an AI/ML diagnostic device. MRMC studies are used for evaluating physician performance with and without AI assistance for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product (gloves), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these gloves is defined by the objective, measurable standards outlined in ASTM D 5250-00 (e.g., specific values for tensile strength, elongation, dimensions) and the performance criteria for the FDA 1000ml water leak test (e.g., maximum allowed pinholes per sample size). It relies on standardized test methods and predefined quantitative thresholds, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set.
§ 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.