(151 days)
A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Patient Examination glove - Disposable- Single use only - Non-sterile - The C2 Powder Free Polyethylene Examination Gloves are made of translucent (clear), . Low Density Polyethylene material and are powder free. The C2 Powder Free Polyethylene Examination Gloves come in five sizes: Small, Medium, Large, X Large and XX Large. The gloves are loose fitting.
The provided document describes the acceptance criteria and the study that proves the AmerCare C2 Powder Free Polyethylene Examination Glove meets those criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Physical Dimensions | Acceptance Criteria (FDA Recognized consensus standard ASTM D 5250-06) | Reported Device Performance (C2 Powder Free Polyethylene Examination Gloves) |
|---|---|---|
| Overall Length | 230 mm minimum | $255 \pm 5$ mm |
| Width (for large glove) | $105 \pm 5$ mm | $105 \pm 5$ mm |
| Palm thickness | 0.08mm minimum | 0.08mm minimum |
| Finger thickness | 0.05mm minimum | 0.05mm minimum |
| Tensile Strength | ||
| Before Aging | 11 MPa minimum | 11 MPa minimum |
| After Aging | 11 MPa minimum | 11 MPa minimum |
| Ultimate Elongation | ||
| Before Aging | 300% minimum | 300% minimum |
| After Aging | 300% minimum | 300% minimum |
| Pinhole AQL | 2.5 | 2.5 |
| Powder-free | Per FDA recognized ASTM D6124-06 | Residual Powder is 0.18mg (meets D6124-06) |
| Water Leakage Testing | Per US 21CFR 800.20 | Yes |
| Biocompatibility | Per ISO 10993-1, 10993-5 and 10993-10 | Not a Primary Skin Irritant; Not a Dermal Sensitizer |
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Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., tensile strength, pinholes). It refers to compliance with recognized standards (ASTM D 5250-06 for physical properties, ASTM D 6124-06 for powder-free, US 21CFR 800.20 for water leakage, and ISO 10993-1, 10993-5, 10993-10 for biocompatibility). These standards typically define the sampling plans and testing methodologies. The provenance of the data is not specified beyond being "non-clinical testing" conducted by AmerCare Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is an examination glove, and its performance is evaluated against material and physical property standards, not through expert-driven ground truth establishment of medical images or conditions.
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Adjudication method for the test set:
This information is not applicable for this type of device and testing. Performance is measured against objective, standardized physical and chemical properties.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or assistive devices where human interpretation is involved. For an examination glove, the "effectiveness" is determined by its physical and material properties meeting established standards, not by human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product (an examination glove), not an algorithm or a software device. The standalone performance refers to the device's physical and chemical attributes, which were tested.
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The type of ground truth used:
The "ground truth" for the performance evaluation of the C2 Powder Free Polyethylene Examination Glove is based on recognized consensus standards for patient examination gloves. Specifically:
- ASTM D 5250-06: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application (applied to polyethylene gloves for substantial equivalence).
- ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- US 21 CFR 800.20: Water Leakage Test.
- ISO 10993-1, 10993-5, 10993-10: Biological evaluation of medical devices (for biocompatibility).
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The sample size for the training set:
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
This information is not applicable. There is no training set for this type of medical 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.