(162 days)
Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text describes the 510(k) summary for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719). This document is a premarket notification for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria.
As such, the information you've requested regarding acceptance criteria, study details, ground truth, and sample sizes is framed within the context of meeting established ASTM (American Society for Testing and Materials) standards for patient examination gloves, rather than a standalone clinical study on the device's diagnostic performance. The device is a physical product (gloves) and not an AI/software device, so many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance) are not applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves are primarily defined by adherence to specific ASTM standards and FDA regulations. The reported device performance is presented as meeting these standards.
| Feature / Test | Acceptance Criteria (from ASTM/Regulation) | Reported Device Performance |
|---|---|---|
| Dimensions - Length | ASTM D5250-06 (Reapproved 2011): ≥230mm min. | 230mm min for all sizes (Meets ASTM D5250-06) |
| Dimensions - Width (Small) | ASTM D5250-06 (Reapproved 2011): 80-90 mm | 85-88 mm (Meets ASTM D5250-06) |
| Dimensions - Width (Medium) | ASTM D5250-06 (Reapproved 2011): 90-100mm | 94-97 mm (Meets ASTM D5250-06) |
| Dimensions - Width (Large) | ASTM D5250-06 (Reapproved 2011): 100-110mm | 103-106mm (Meets ASTM D5250-06) |
| Dimensions - Width (X-Large) | ASTM D5250-06 (Reapproved 2011): 110-120 mm | 113-115 mm (Meets ASTM D5250-06) |
| Dimensions - Thickness (Finger) | ASTM D5250-06 (Reapproved 2011): 0.05mm min. | 0.05mm min. (Meets ASTM D5250-06) |
| Dimensions - Thickness (Palm) | ASTM D5250-06 (Reapproved 2011): 0.08mm min. | 0.08mm min. (Meets ASTM D5250-06) |
| Physical Properties (Before/After Aging) - Elongation | ASTM D5250-06 (Reapproved 2011): ≥300% | ≥300% (Meets ASTM D5250-06) |
| Physical Properties (Before/After Aging) - Tensile Strength | ASTM D5250-06 (Reapproved 2011): ≥14MPa | ≥14MPa (Meets ASTM D5250-06) |
| Freedom from Pinholes (Water Leak Test) | 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011); Inspection Level I, AQL 2.5 | Meets criteria (implied by "Substantially equivalent" and general statement) |
| Residual Powder | ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Meets criterion) |
| Biocompatibility (Skin Irritation/Sensitization) | ISO 10993-10:2002/Amd.1:2006 (for predicate); ISO 10993-10 Third Edition 2010-08-01 (for subject device) | Non-irritant and non-sensitizer (Meets criterion) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample sizes for each test in the batch of gloves. It refers to meeting ASTM standards, which would imply that the testing followed the sampling methodologies outlined in those standards (e.g., AQL levels for pinhole testing).
- Data Provenance: The tests are conducted on the manufactured "Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves" by Xinfu Medical Products Co., Ltd. The testing would be conducted in China (East of Lipingtuo, Luannan County, Tangshan City, 063502 Hebei Province, China) and are likely retrospective data from product testing batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable in the context of this device. The "ground truth" for these physical performance tests (e.g., glove dimensions, tensile strength, pinholes, residual powder) is established by adherence to quantitative and qualitative criteria defined within the referenced ASTM standards, not by expert consensus in a diagnostic sense. These tests are performed by laboratory technicians or quality control personnel using calibrated equipment and standardized procedures.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements or binary pass/fail based on established standards, not subjective assessments requiring 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 device is a physical medical glove, not an AI/software device. Therefore, no MRMC study or AI performance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove, not an AI/software device. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is the adherence to the quantitative and qualitative specifications outlined in the referenced ASTM standards and FDA regulations. For example:
- Dimensions: Measured values must fall within the ranges specified by ASTM D5250-06.
- Tensile Strength/Elongation: Measured values must meet or exceed the minimum requirements of ASTM D5250-06.
- Freedom from Pinholes: The number of pinholes in a sample must meet the Acceptable Quality Level (AQL) of 2.5 per ASTM D5151-06 and 21 CFR 800.20.
- Residual Powder: The measured powder residue must be below the limit specified by ASTM D6124-06 (below 2mg).
- Biocompatibility: Results from established biological tests (e.g., ISO 10993-10) must indicate non-irritancy and non-sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/machine learning model that requires a training set. The compliance is based on testing production samples against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical product like a patient examination glove.
§ 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.