(114 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.
This document describes the performance testing for a medical device: "Nitrile Patient Examination Glove" (K222527). The tests demonstrate that the device meets established acceptance criteria, primarily through non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | Grades less than 1, otherwise sensitization. |
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | 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.