(280 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).
The provided text describes the acceptance criteria and the study results for the "YONGFA Powder-Free Vinyl Patient Examination Gloves, Clear (non-colored)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM D5250-06 (Reaffirmation 2011) standard for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for freedom from pinholes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder, as well as biocompatibility standards.
| Feature & Description | Acceptance Criteria (from ASTM/ISO Standards) | Reported Device Performance |
|---|---|---|
| Device Description & Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions - Length | ≥ 230mm min (ASTM D5250-06) | ≥ 230mm min for all sizes (Meets ASTM D5250-06) |
| Dimensions - Width | Small: 80-90 mm; Medium: 90-100 mm; Large: 100-110 mm; X Large: 110-120 mm (ASTM D5250-06) | Small: 86-89 mm; Medium: 94-97 mm; Large: 105-107 mm; X Large: 115-118 mm (Meets ASTM D5250-06) |
| Dimensions - Thickness | Finger: ≥ 0.05mm min; Palm: ≥ 0.08mm min (ASTM D5250-06) | Finger: ≥ 0.05mm min; Palm: ≥ 0.08mm min (Meets ASTM D5250-06) |
| Physical Properties | Before aging/after aging: Elongation ≥ 300%; Tensile Strength ≥ 11MPa (ASTM D5250-06) | Before aging/after aging: Elongation ≥ 300%; Tensile Strength ≥ 11MPa (Meets ASTM D5250-06) |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Inspection Level I, AQL 2.5) | Meets ASTM D5151-06 (Inspection Level I, AQL 2.5) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Meets ASTM D6124-06) |
| Biocompatibility | Not an irritant; Not a sensitizer (ISO 10993-10) | Under the conditions of the study, not an irritant; Under conditions of the study, not a sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each specific characteristic (e.g., number of gloves tested for tensile strength or pinholes). However, the testing is based on meeting ASTM standards (D5250-06, D5151-06, D6124-06) and ISO 10993-10. These standards typically prescribe sampling plans and methodologies.
The provenance of the data is not directly stated as "retrospective" or "prospective". However, given that this is a 510(k) submission for a new device claiming substantial equivalence to an existing one, the tests would have been performed by the manufacturer, Yongfa Glove Co., Ltd., which is located in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For medical gloves, "ground truth" is typically established by recognized national/international standards and testing protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1) is not applicable to the type of device and testing described. Adjudication methods are typically used in clinical studies where human interpretation of medical images or patient conditions needs to be resolved among multiple experts. For gloves, the assessment is based on objective measurements against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance (with and without aid) is evaluated. This document concerns the physical and biological properties of patient examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical glove, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. Type of Ground Truth Used
The ground truth used for evaluating the device is based on established industry standards and regulatory requirements:
- ASTM Standard D5250-06 (Reaffirmation 2011): Standard Specification for Vinyl Patient Examination Gloves.
- ASTM Standard D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM Standard D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10 Third Edition 2010-08-01: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
- 21 CFR 800.20: Subpart B - Performance Standards and Requirements for Medical Devices; General.
These standards define the measurable physical properties and acceptable limits for performance characteristics of the gloves.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI algorithms 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 type, this question is not relevant.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.