(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). 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. 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.
The provided text describes information for the Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) . Based on the text, here's a description of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from ASTM D5250-06 unless otherwise specified) | Reported Device Performance (Yonghe Plastic Products Co., Ltd.) |
|---|---|
| Dimensions | Meets ASTM D5250-06 (Reapproved 2011) |
| - Length: $\geq 230$ mm min. | 230 mm min for all sizes |
| - Width (Small) | 86-89 mm |
| - Width (Medium) | 95-97 mm |
| - Width (Large) | 105-108 mm |
| - Width (X Large) | 115-117 mm |
| - Thickness (Finger): $\geq 0.05$ mm min. | 0.05 mm min. |
| - Thickness (Palm): $\geq 0.08$ mm min. | 0.08 mm min. |
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011) |
| - Elongation: $\geq 300%$ (Before aging/after aging) | $\geq 300%$ (Before aging/after aging) |
| - Tensile Strength: $\geq 11$ MPa (Before aging/after aging) | $\geq 11$ MPa (Before aging/after aging) |
| Freedom from Pinholes | Meets ASTM D5151-06 (Reapproved 2011) |
| - (Specific AQL or criteria as per ASTM D5151-06) | Holes Inspection Level I, AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) |
| - (Specific criteria as per ASTM D6124-06) | Results generated values below 2mg of residual powder |
| Biocompatibility | Meets ISO 10993-10 Third Edition 2010-08-01 |
| - Non-irritant | Not an irritant |
| - Non-sensitizer | Not a sensitizer |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for testing each specific characteristic (e.g., number of gloves tested for pinholes, tensile strength, etc.).
- Data Provenance: The studies were conducted by Yonghe Plastic Products Co., Ltd. in China, as indicated by the submitter's address and the manufacturer's location. The data appears to be a retrospective report of testing conducted by the manufacturer to demonstrate compliance with relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish a "ground truth" for the test set in the context of human assessment or clinical evaluation. The ground truth for device performance is based on the objective measurement and adherence to the specified ASTM and ISO standards by the manufacturer.
4. Adjudication method for the test set:
- Not applicable as the assessment relies on objective measurements against engineering standards, not subjective human interpretations requiring adjudication.
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:
- Not applicable. This device is a patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used:
- The ground truth is established by objective technical standards and measurement specifications as defined by:
- ASTM D5250-06 (Reaffirmation 2011) for patient examination gloves.
- ASTM D5151-06 (Reapproved 2011) for freedom from holes in medical gloves.
- ASTM D6124-06 (Reaffirmation 2011) for residual powder on medical gloves.
- ISO 10993-10 Third Edition 2010-08-01 for biocompatibility (irritation and sensitization).
- 21 CFR 800.20 (presumably related to acceptable quality limits for pinholes).
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As described above, there is no training set for this type of 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.