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510(k) Data Aggregation
(87 days)
The Vinyl Patient Examination Glove (Yellow) 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 yellow. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| ITEM | Acceptance Criteria (Proposed Device K173561) | Reported Device Performance (Proposed Device K173561) |
|---|---|---|
| Product Code | LYZ | LYZ |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Class | I | I |
| Intended Use | Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner. | Meets this description. |
| Powdered or Powered free | Powder-free | Powder-free |
| Design Feature | Ambidextrous | Ambidextrous |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Meets these requirements. |
| Dimensions (Length, Width) | Complies with ASTM D 5250 specifications (specific values depend on size: e.g., Length min 230mm, Width ±5mm of specific values) | All proposed device meets the specifications of ASTM D 5250. |
| Thickness (Finger, Palm) | Finger: 0.05 min, Palm: 0.08 min | Finger: 0.05 min, Palm: 0.08 min |
| Colorant | Yellow | Yellow |
| Physical Properties | Before Aging: Tensile Strength: 12 MPa, min; Ultimate Elongation: 300 % min | Achieved 12 MPa, min (Tensile Strength); 300 % min (Ultimate Elongation) |
| After Aging: Tensile Strength: 12 MPa, min; Ultimate Elongation: 300 % min | Achieved 12 MPa, min (Tensile Strength); 300 % min (Ultimate Elongation) | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 Level=G-I, AQL=1.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=1.5 |
| Powder Content | Meets the requirements of ASTM 5250 | 1.7 mg (within ASTM 5250 requirements for powder-free, which is < 2mg) |
| Material | Vinyl | Vinyl |
| Biocompatibility | Irritation: not an irritant (under study conditions) | Met (evaluated per ISO 10993-10) |
| Sensitization: not a sensitizer (under study conditions) | Met (evaluated per ISO 10993-10) | |
| Cytotoxicity: did not show potential toxicity to L-929 cells (under study conditions) | Met (evaluated per ISO 10993-5) | |
| Label and Labeling | Meets FDA's Requirements of 21 CFR 801 | Meets FDA's Requirements of 21 CFR 801 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for biocompatibility). However, it indicates compliance with recognized standards that prescribe sampling methods.
- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard outlines sampling procedures to determine freedom from holes.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection: This standard was used for sampling procedures.
The data provenance is from non-clinical laboratory testing performed by or for Yurun Glove Co., Ltd. in China. The study is prospective in the sense that tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device (a medical glove) is established through adherence to recognized international and national consensus standards (e.g., ASTM, ISO) for physical properties, barrier integrity, and biocompatibility, rather than expert consensus on interpretive data like medical images. The "experts" would be the certified laboratories and personnel performing the standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is measured against objective, standardized laboratory tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically performed for AI/CAD devices involving interpretation of medical images or data by human readers. This device is a medical glove, and its performance is assessed via non-clinical laboratory tests.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This concept is not applicable to a physical medical device like a glove. The device itself is not an algorithm.
7. Type of Ground Truth Used
The ground truth is based on:
- Established consensus standards: Such as ASTM D5250 for Poly(vinyl chloride) Gloves for Medical Application, ASTM D6124 for Residual Powder, ASTM D5151 for Detection of Holes, ISO 10993-10 for Irritation and Sensitization, and ISO 10993-5 for Cytotoxicity. These standards define the acceptable performance parameters.
- Objective laboratory measurements: The device's physical properties (e.g., tensile strength, elongation, thickness, freedom from holes, powder content) and biocompatibility are measured against the specifications outlined in these standards.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve AI/machine learning requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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