(319 days)
Powder Free Vinyl 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).
Here's a breakdown of the acceptance criteria and the study verifying the performance of the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature & Description | Acceptance Criteria (from ASTM D5250-06 unless specified) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| -- Length | ≥ 230mm for all sizes (ASTM D5250) | Meets ASTM D5250-06 (Reapproved 2011) |
| -- Width (Small) | 80-90 mm (ASTM D5250) | 80-85 mm |
| -- Width (Medium) | 90-100 mm (ASTM D5250) | 95-97 mm |
| -- Width (Large) | 100-110 mm (ASTM D5250) | 102-108 mm |
| -- Width (X-Large) | 110-120 mm (ASTM D5250) | 114-118 mm |
| -- Thickness (Finger) | ≥ 0.05 mm | 0.05 mm min. |
| -- Thickness (Palm) | ≥ 0.08 mm | 0.08 mm min. |
| Physical Properties | ||
| -- Elongation | ≥ 300% (before/after aging, ASTM D5250) | ≥ 300% (before/after aging) |
| -- Tensile Strength | ≥ 14 MPa (before/after aging, ASTM D5250) | ≥ 14 MPa (before/after aging) |
| Freedom from Pinholes | ||
| -- AQL | 2.5 (Inspection Level I, ASTM D5151-06, 21 CFR 800.20) | Meets ASTM D5151-06 (Reapproved 2011) |
| Residual Powder | ASTM D6124-06 | Below 2mg of residual powder (meets ASTM D6124-06) |
| Material/Composition | PVC | PVC |
| Donning Lubricant | If used, composition and biocompatibility data (ISO 10993-10) should be provided | PU / Surface Coating Agent |
| Biocompatibility | Skin Irritation, Dermal, and Sensitization Studies (ISO 10993-10:2002/Amd.1:2006) | Meets ISO 10993-10:2002/Amd.1:2006 |
| Sterility Status | Non-sterile | Non-sterile |
| Single Patient Use | Single Patient Use | Single Patient Use |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for pinholes, tensile strength, 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: 2002/Amd. 1:2006(E)." This implies that the testing was conducted according to these established standards, which would have their own specified sample size requirements.
The data provenance is not explicitly mentioned as retrospective or prospective, or country of origin for the specific test data. However, the submitter is Hope Plastic Co., Ltd. from China, suggesting the testing was likely performed by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this type of device and study. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized consensus standards (ASTM, ISO, CFR) rather than expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. For objective physical testing of medical gloves, the results are typically quantitative and directly compared to the specified criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted diagnostic devices, often comparing human reader performance with and without AI. This device is a physical medical glove and does not involve AI or human "readers" in a diagnostic capacity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical product, not an algorithm, and therefore does not have standalone algorithm performance.
7. The Type of Ground Truth Used
The ground truth used for verifying the device's performance is based on objective measurements and laboratory testing results compared against established consensus standards. Specifically:
- ASTM D5250-06 (Reaffirmation 2011) for physical properties (dimensions, tensile strength, elongation).
- ASTM D5151-06 (Reaffirmation 2011) for freedom from pinholes.
- ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- 21 CFR 800.20 for water leak tests (related to pinholes).
- ISO 10993-10: 2002/Amd. 1:2006 (E) for biocompatibility (skin irritation, dermal, and sensitization studies).
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.