(164 days)
A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
The Safeskin PFE-XTRA Latex Examination Glove underwent testing to demonstrate its substantial equivalence to predicate devices and adherence to relevant standards.
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standards (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Physical Properties | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 3578-99 | Meets ASTM D 3578-99 |
| Freedom from pinholes | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Powder-Free | Meets ASTM D 6124 (4 mg/glove maximum) | Meets ASTM D 6124 (4 mg/glove maximum) |
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes used for each individual test (Dimensions, Physical Properties, Freedom from pinholes, Powder-Free, Biocompatibility). However, the tests are laboratory-based, adhering to predefined ASTM standards.
- Data Provenance: The data is generated from laboratory testing against established ASTM (American Society for Testing and Materials) standards. This indicates a prospective testing methodology. The country of origin of the data is not explicitly stated, but the submission is to the FDA in the USA.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is not an AI/ML powered device, therefore, the concept of establishing ground truth with experts in the typical sense for image interpretation or diagnosis does not apply. The "ground truth" here refers to the objective measurements and pass/fail criteria defined by the ASTM standards themselves. These standards are developed through a consensus process by experts in the field of materials science and medical devices.
4. Adjudication Method for Test Set
Not applicable. The tests are based on objective measurements and adherence to specific ASTM standard specifications, rather than subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML powered device, and no MRMC study was performed or required. The device is a physical medical examination glove. Clinical data were explicitly stated as "not needed for examination gloves" [9].
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used (Test Set)
The ground truth for the performance claims is derived from established ASTM standards for medical examination gloves. These standards specify objective physical, chemical, and biological properties that the gloves must meet.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for a physical product, the concept of establishing ground truth for a training set does not apply.
§ 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.