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510(k) Data Aggregation
(155 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. 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. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM DS250-06(Reapproved 2011) and ASTM D5151-06(Reapproved 2011) requirements.
The provided text describes the acceptance criteria and performance of Powder Free Vinyl Patient Examination Gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011) | Meets (<2mg/glove) |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits ISO 10993-10:2002/Amd.1:2006 | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in the guinea pig ISO 10993-10:2002/Amd.1:2006 | Passes (Not a Dermal sensitization) |
| Dimensions (Length) | ASTM D5250-06 (Reapproved 2011) ≥230mm min. | 230mm min for all sizes |
| Dimensions (Width) | ASTM D5250-06 (Reapproved 2011) (Small: 80-90mm, Medium: 90-100mm, Large: 100-110mm, Xlarge: 110-120mm) | (Small: 80-85mm, Medium: 95-100mm, Large: 102-108mm, Xlarge: 113-118mm) - Considered Substantially Equivalent |
| Dimensions (Thickness) | ASTM D5250-06 (Reapproved 2011) (Finger: 0.05mm min., Palm: 0.08mm min.) | (Finger: 0.09-0.12mm, Palm: 0.09-0.12mm) - Considered Substantially Equivalent |
| Physical Properties (Elongation) | ASTM D 5250-06 (Reapproved 2011) (Before aging/after aging: ≥300%) | (Before aging/after aging: 390-420%) - Considered Substantially Equivalent |
| Physical Properties (Tensile Strength) | ASTM D 5250-06 (Reapproved 2011) (Before aging/after aging: ≥14MPa) | (Before aging/after aging: 15-20 MPa) - Considered Substantially Equivalent |
| Freedom from Pinholes (AQL) | ASTM D5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) - Holes at Inspection Level I AQL2.5 |
| Materials used | PVC | PVC |
| Dusting or Donning Powder | PU or Surface Coating Agent | PU / Surface Coating Agent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test (e.g., number of gloves tested for pinholes, physical properties, or biocompatibility). It references adherence to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not specified, but the manufacturer is based in Jiangsu, China, so it can be inferred that testing was conducted either internally or by laboratories associated with the manufacturer, likely in China. The studies are non-clinical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a patient examination glove, and its performance is evaluated against engineering and biological standards (ASTM, ISO, CFR), not against expert clinical judgment for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there's no diagnostic judgment involved that would require adjudication. Performance is measured against objective 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. The device is a physical product (gloves), not an AI-assisted diagnostic tool.
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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the requirements of the specified international and national standards:
- ASTM standard D 5250-06 (Reapproved 2011) for dimensions and physical properties.
- 21 CFR 800.20 for freedom from pinholes.
- ASTM standard D 6124-06 (Reapproved 2011) for powder residual.
- ISO 10993-10:2002/Amd.1:2006 for biocompatibility (skin irritation and sensitization).
These standards provide objective, measurable criteria for the device's performance characteristics.
8. The sample size for the training set
This information is not applicable. The device is a manufactured 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, as there is no training set for this type of device.
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