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510(k) Data Aggregation
(330 days)
Powder Free Viny! Patient Examination Gloved) is a non-sterile disposable device intended for medical purposs 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. Its 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.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (from ASTM/FDA Guidance) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Dimensions - Length | ASTM D5250: 230mm min for all sizes | 230mm min for all sizes | Substantially equivalent |
| Dimensions - Width | ASTM D5250: 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 |
| Dimensions - Thickness | ASTM D5250: Finger 0.05mm min, Palm 0.08mm min | Finger 0.05mm min, Palm 0.08mm min | Substantially equivalent |
| Physical Properties (Aging) | ASTM D5250: Before aging/after aging: Elongation ≥300%, Tensile Strength >14MPa | Before aging/after aging: Elongation ≥300%, Tensile Strength ≥ 14MPa | Substantially equivalent |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D5250, ASTM D 5151; AQL 2.5 (Inspection Level I) | Meets ASTM D5151-06 (Reapproved 2011), Holes Inspection Level I, AQL 2.5 | Substantially equivalent |
| Residual Powder | ASTM D 6124 (values below 2mg of residual powder) | Meets ASTM D 6124-06 (Reapproved 2011), Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials | Polymer/other type of material identification (If vinyl: PVC) | PVC | Substantially equivalent |
| Donning Powder/Lubricant | Composition and biocompatibility data if lubricant used | PU (Polyurethane) / Surface Coating Agent | Substantially equivalent |
| Sterility status | Non sterile | Non sterile | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES (ISO 10993-10) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 | Substantially equivalent |
| Labeling | -Powder Free, -Patient Examination Glove, -Single Use Only, - Manufactured For:, -Lot | -Powder Free, -Patient Examination Glove, -Single Use Only, - Manufactured For:, -Lot | 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 testing each of the acceptance criteria (e.g., number of gloves tested for dimensions, pinholes, tensile strength). Instead, it refers to compliance with ASTM standards (D5250, D5151, D6124) which inherently define the sampling plans and test procedures for these performance characteristics. The provenance of the data is implied to be from the manufacturer (Jewel Plastic Co., Ltd.) as they are reporting that their device "Meets" these standards. No specific country of origin for the test data is mentioned, nor is it specified whether the studies were retrospective or prospective, though testing against an ASTM standard is typically a prospective and controlled laboratory evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the acceptance criteria are based on objective, quantifiable physical and performance characteristics defined by recognized consensus standards (ASTM D5250, D5151, D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10). Expert clinical or image-based "ground truth" is not established for these types of device characteristics. The "ground truth" is the standard itself.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. The testing involves standardized measurements and procedures, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers improve with AI vs without AI assistance
This information is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (gloves), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance against its acceptance criteria is consensus standards and regulatory requirements. Specifically, this includes:
- ASTM D5250-06 (Reaffirmation 2011): Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
- ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves
- 21 CFR 800.20: Subpart B - Performance Standards, specific to medical devices (likely related to leakage testing).
- 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 measurable properties and the acceptable limits for those properties.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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