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510(k) Data Aggregation
(273 days)
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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.
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Please find the acceptance criteria and study details based on the provided text. Due to the nature of the device (patient examination gloves), the "study" is a series of performance tests against established standards, rather than a clinical study involving human readers or AI.
Device: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves (K131341)
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is gauged against established ASTM standards for patient examination gloves, primarily ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmation 2011), and ASTM D6124-06 (Reaffirmation 2011). The acceptance criteria are the minimum requirements specified by these standards.
| Feature & Description | Acceptance Criteria (from ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Intended Use | Disposable device for medical purposes, worn to prevent contamination between patient and examiner. | Disposable device for medical purposes, worn to prevent contamination between patient and examiner. | Substantially equivalent |
| Length | ≥230mm min. (ASTM D5250-06) | 230mm min for all sizes | Substantially equivalent |
| Width | Meets ASTM D5250-06 specifications: Small 80-90 mm, Medium 90-100mm, Large 100-110mm, X large 110-120 mm | Small 80-85 mm, Medium 95-97 mm, Large 102-108mm, X large 114-118 mm | Substantially equivalent |
| Thickness | Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250-06) | Finger 0.05mm min., Palm 0.08mm min. | Substantially equivalent |
| Physical Properties (Before aging/after aging) | Elongation ≥300%, Tensile Strength ≥14MPa (ASTM D5250-06) | Elongation ≥300%, Tensile Strength ≥ 14MPa | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Inspection Level I, AQL 2.5) | Meets ASTM D5151 (Holes Inspection Level I, AQL 2.5) | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (≤2mg of residual powder, for powder-free classification) | Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials Used | PVC | PVC | Substantially equivalent |
| Dusting/Donning Powder | PU (as surface coating agent) | PU (as Surface Coating Agent) | Substantially equivalent |
| Performance Data Supporting Substantial Equivalence | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Meets ASTM D5151-06, ASTM D5250-06, ASTM D6124-06 | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Biocompatibility | (Expected to be non-irritant/non-sensitizer per ISO 10993-10) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10. The test article was a non-irritant or non-sensitizer. | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each physical and performance test (e.g., number of gloves tested for tensile strength, pinholes, etc.). However, it indicates that the tests were conducted in accordance with ASTM standards. These standards typically specify the sampling plans and test methods.
Data Provenance: The tests are implied to be conducted by the manufacturer, Shijiazhuang Winful Plastic Co., Ltd. The data is retrospective, as it pertains to measurements taken on the manufactured gloves to demonstrate compliance with standards for the 510(k) submission. The company's address is listed as: No.6 Cangshi Road, Jinzhou City, Hebei, 052260, China. Therefore, the data originates from China.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a medical glove, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for the performance characteristics of the gloves is established by the specified ASTM standards and the validated methodologies for performing the tests detailed within those standards.
4. Adjudication Method for the Test Set
This is not applicable. The "adjudication method" concept is relevant for studies involving subjective human interpretation or AI outputs, where multiple experts might disagree on a "ground truth" label. For this device, the tests involve objective measurements against quantitative physical and chemical specifications from established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. An MRMC study is designed to evaluate the diagnostic performance of a system (often AI-assisted) compared to human readers. This device is a physical product (medical glove) and does not involve diagnostic interpretation or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This concept applies to AI algorithms. The device is a physical product.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is compliance with established national and international consensus standards:
- ASTM D5250-06 (Reaffirmation 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
- ASTM D5151-06 (Reaffirmation 2011) - Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
- 21 CFR 800.20 - General provisions regarding medical devices. (specifically for waterleak test on pinhole AQL)
- ISO 10993-10: 2002/Amd. 1:2006(E) - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
These standards define the acceptable physical properties, performance, and safety requirements for patient examination gloves.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable. As there is no training set for a physical product, there is no corresponding ground truth establishment process. The "ground truth" for the product's design and manufacturing quality is derived from its adherence to the aforementioned ASTM and ISO standards.
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