(93 days)
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.
This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.
| Test / Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Irritation (ISO 10993-10:2010) | Primary Irritation Index: 0-0.4 (Negligible) | Primary irritation index is 0. Response categorized as negligible. All animals survived with no abnormal signs. |
| Sensitization (ISO 10993-10:2010) | Grades less than 1 (no sensitization) | All grades are 0. Not a sensitizer under study conditions. |
| Cytotoxicity (ISO 10993-5:2009) | Viability (viab.%) of 100% extract ≥ 70% of blank (no cytotoxic potential) | Viab.% of 100% test article extract is 70.9%. No potential toxicity to L-929 in MTT method. |
| Physical Properties | ||
| Residual Powder (ASTM D6124-06) |
§ 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.