(138 days)
A disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.
Non-Sterile E.P. Latex Examination Gloves, meet all of the requirements of ASTM D 3578. Non-Sterile E.P. Latex Examination Gloves meet all the current specifications for ASTM D 3578 Rubber Examination Gloves. Non-Sterile E.P. Latex Examination Gloves are non-sterile disposable devices intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. Non-Sterile E.P. Latex Examination Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards.
The acceptance criteria for the Non-Sterile E.P. Latex Examination Gloves and the reported device performance are presented in the following table:
| Characteristics | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Physical Properties | Meets ASTM D 3578 | Meets ASTM D 3578 |
| Freedom from holes | Meets ASTM D 5151 (FDA hole requirements) | Meets ASTM D 5151 |
| Powder Content | Not more than 2 mg residue by mass (ASTM D 6124) | Powder-Free; Meets described test in Attachment VIII; Not more than 2 mg residue by mass |
| Biocompatibility (Primary Skin Irritation in Rabbits) | Passes | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Passes | Passes |
Study Details:
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Sample size used for the test set and data provenance:
The document states that "The performance test data of the non clinical tests are the same as mentioned immediately above." This implies that the tests were conducted by Ansell Perry Inc. to demonstrate the device's adherence to the specified ASTM standards and biocompatibility requirements. The exact sample sizes for each test are not explicitly provided in this summary. The data provenance is internal to the manufacturer (Ansell Perry Inc.) for non-clinical tests. Clinical data was not deemed necessary for this type of medical device. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device's performance is gauged against established industry standards (ASTM) and regulatory requirements (FDA hole requirements, biocompatibility tests). Ground truth is established by these objective standards and test methodologies, not by expert consensus on individual cases. -
Adjudication method for the test set:
Not applicable. The tests are designed to objectively measure specific characteristics against predefined limits set by the standards. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The device is a medical glove, and its performance is evaluated based on physical properties and biocompatibility, not on interpretive clinical readings by humans. -
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance tests described (dimensions, physical properties, freedom from holes, powder content, biocompatibility) are standalone evaluations of the glove's characteristics without a human-in-the-loop component for interpretation. These are material science and biological compatibility tests. -
The type of ground truth used:
The ground truth used is based on established, objective, and quantitative standards (ASTM D 3578, ASTM D 5151, ASTM D 6124, and specific biocompatibility test protocols for primary skin irritation and guinea pig sensitization). Compliance with these numerical and qualitative criteria constitutes the ground truth. -
The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the development and manufacturing processes to consistently produce gloves meeting the specifications. -
How the ground truth for the training set was established:
Not applicable. As noted above, this is not an AI/machine learning 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.