(66 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Safeskin Purple Nitrile Examination Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Safeskin Purple Nitrile Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standards / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Physical Properties | Meets ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Freedom from pinholes | Meets ASTM D 6319-99 | |
| Meets ASTM D 5151 | Meets ASTM D 6319-99 | |
| Meets ASTM D 5151 | ||
| Powder-Free | Meets ASTM D 6124 | |
| 2 mg/glove maximum | Meets ASTM D 6124 | |
| 2 mg/glove maximum | ||
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes | |
| Chemotherapeutic Agent Permeation | ASTM F 739-96 | Passes ASTM F 739-96 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the testing, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the data for each test. The testing is implied to be for product validation against ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic algorithm performance. The device's performance is assessed against established ASTM standards, which themselves are developed by expert consensus in their respective fields but not as part of this device-specific submission.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" typically refers to how discrepancies in expert opinions are resolved to establish ground truth for a diagnostic study. Here, the device is evaluated against predefined, objective ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a device like examination gloves. The device is a standalone product.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire submission details the performance of the Safeskin Purple Nitrile Examination Glove itself against established industry (ASTM) and internal standards without human intervention influencing the device's function. The results indicate that the device "will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product."
7. Type of Ground Truth Used
The "ground truth" used for this device's evaluation is primarily based on established industry standards (ASTM) for physical properties, dimensions, freedom from pinholes, powder content, biocompatibility, and chemotherapeutic agent permeation. There is no mention of pathology, expert consensus (in the context of clinical reads), or outcomes data as the primary ground truth for these product characteristics.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (examination gloves) and does not involve AI or machine learning models that require training data. The "training data" here would metaphorically be the experience and research that went into the glove's design, but not in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
§ 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.