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510(k) Data Aggregation
(119 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.
This document describes testing performed for the Nacrous Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142342).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (from ASTM D5250-06 (Reaff 2011), ASTM D5151-06 (Reaff 2011), ASTM D6124-06 (Reaff 2011), 21 CFR 800.20, and ISO 10993-10:2002/Amd.1:2006) | Reported Device Performance (Nacrous Powder Free Vinyl Patient Examination Gloves) |
|---|---|---|
| Dimensions | ||
| Length | ≥230mm min. | 230mm min for all sizes (Similar to predicate) |
| Width (Small) | 80-90 mm | 85-88 mm (Similar to predicate) |
| Width (Medium) | 90-100mm | 95-97 mm (Similar to predicate) |
| Width (Large) | 100-110mm | 105-107mm (Similar to predicate) |
| Width (X-Large) | 110-120 mm | 113-114 mm (Similar to predicate) |
| Thickness (Finger) | 0.05mm min. | 0.05mm min. (Similar to predicate) |
| Thickness (Palm) | 0.08mm min. | 0.08mm min. (Similar to predicate) |
| Physical Properties | ||
| Elongation (Before/After Aging) | ≥300% | ≥300% (Similar to predicate) |
| Tensile Strength (Before/After Aging) | ≥11MPa | ≥11MPa (Similar to predicate) |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reaff 2011), ASTM D 5151-06 (Reaff 2011) | Meets ASTM D5151-06 (Reaff 2011), Inspection Level I, AQL 2.5 (Similar to predicate) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Similar to predicate) |
| Biocompatibility (Skin Irritation & Sensitization) | Meets ISO 10993-10:2002/Amd.1:2006 (for predicate) / ISO 10993-10, Third Edition 2010-08-01 (for subject device) | Under the conditions of the study, the device is not a sensitizer or an irritant. (Similar to predicate) |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., length, width, thickness, pinholes, etc.). However, it indicates that the device "meets requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01." These ASTM and ISO standards would specify the required sampling plans and statistical methods for demonstrating compliance.
The data provenance is from China, as the submitter, Nacrous Plastic Co., Ltd., is located in China. The testing appears to be retrospective, as it's a submission for premarket notification (510(k)) based on tests performed on the manufactured product to demonstrate equivalence to a predicate device and relevant standards.
3. Number of Experts and Qualifications
This information is not provided in the document. The tests described are primarily physical and material property evaluations against established industry standards (ASTM, ISO), rather than clinical assessments requiring expert interpretation of results.
4. Adjudication Method
This information is not applicable for the type of testing described in the document, which focuses on device performance against objective standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human reader performance is a critical factor, and assessing the impact of AI assistance is relevant. For patient examination gloves, the performance evaluation is based on meeting physical and material standards.
6. Standalone Performance
A standalone performance evaluation (algorithm only, without human-in-the-loop) was done in the sense that the physical and material properties of the gloves were tested directly against specified standards (ASTM, ISO) without human interaction influencing the outcome of these tests. However, it's not a "standalone algorithm" in the context of AI software.
7. Type of Ground Truth Used
The ground truth used for performance validation is based on:
- Established Industry Standards: ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmation 2011), ASTM D6124-06 (Reaffirmation 2011).
- Regulatory Requirements: 21 CFR 800.20 (Freedom from Pinholes).
- International Standards: ISO 10993-10 Third Edition 2010-08-01 (Biocompatibility - Skin Irritation & Sensitization).
These standards define the acceptable range or threshold for each physical and material characteristic of the gloves.
8. Sample Size for the Training Set
This information is not applicable as this device is a physical product (patient examination glove), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a physical product and does not involve a training set.
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