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510(k) Data Aggregation
(151 days)
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
How the device functions: PVC films form a barrier to body fluids and bloodborne Pathogens
Scientific concepts that form the basis for the device: The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided document describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission aims to demonstrate substantial equivalence to a predicate device already on the market (K120968).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate/ASTM Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Dimensions - Length | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Dimensions - Width | ≥230mm min. (overall)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm (specific sizes) | 230mm min for all sizesSmall 87-90 mmMedium 94-97 mmLarge 104-108mmX large 114-117 mm | Substantially equivalent |
| Dimensions - Thickness | Meets ASTM D5250-06 (Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Substantially equivalent |
| Physical Properties (Before/After Aging) | Elongation ≥300%Tensile Strength ≥11MPa (Meets ASTM D5250-06 Reapproved 2011) | Elongation ≥300%Tensile Strength ≥11MPa (Meets ASTM D5250-06 Reapproved 2011) | Substantially equivalent |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D 5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011)Holes Inspection Level IAQL 2.5 | Substantially equivalent |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011)Results generated values below 2mg of residual powder | Substantially equivalent |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 | The test article was a non-irritant or non-sensitizer.SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., for dimensions, tensile strength, pinholes, residual powder, or biocompatibility). It references ASTM standards (D5250-06, D5151-06, D6124-06) and ISO 10993-10, which would dictate the required sample sizes for such tests.
The data provenance is not explicitly stated. However, given that the submitter is "Shuntong Glove Co., Ltd." from China, it is highly likely that the testing and data generation occurred in China. The study is retrospective in the sense that the results are presented as already obtained data to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of device and tests conducted. The "ground truth" for glove performance is established by standardized test methods and quantitative measurements against defined criteria in ASTM and ISO standards, not by expert consensus on qualitative data.
4. Adjudication Method for the Test Set
Not applicable. As described above, performance is measured against objective standards, not through adjudication of subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. For examination gloves, the demonstration of effectiveness primarily relies on physical and mechanical properties, not human interpretation. The study is a comparison of product specifications and performance to established industry standards and a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. Examination gloves are physical devices, not algorithms. The performance evaluation focuses on the inherent characteristics of the glove material and manufacturing quality.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective, quantitative measurements against established engineering and material science standards (ASTM and ISO standards). For example:
- Physical dimensions (length, width, thickness) are measured directly.
- Physical properties (elongation, tensile strength) are determined through mechanical testing.
- Freedom from pinholes is assessed using a water leak test specified in ASTM D5151-06.
- Residual powder is measured gravimetrically as per ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is assessed via standardized in-vivo testing as per ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of device performance evaluation for examination gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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