(76 days)
The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.
Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.
Here's the relevant information based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.
Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:
| Test | Methodology / Standard | Purpose | Acceptance Criteria | Reported Performance/Results |
|---|---|---|---|---|
| Biocompatibility | ||||
| Irritation & Skin Sensitization | ISO 10993-10:2010 | Assess possible contact hazards from chemicals, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization. | |
| Skin Irritation Test: Primary irritation index: 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). | Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs observed. | |||
| Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible. | ||||
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Assess the in vitro cytotoxicity of medical devices. | Viability reduced to |
§ 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.