(58 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.
The document provided is a 510(k) summary for Disposable Nitrile Powder-Free Examination Gloves. It details the safety and effectiveness information, comparing the proposed device to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance testing rather than studies involving human readers or AI.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| No. | Name of the Test Methodology / Standard | Acceptance Criteria | Results |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization) | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. |
| 2 | ISO 10993-10:2010 (Skin Irritation) | Skin Irritation Test: 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. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | The viab.% of the 100% extract of the test article is the final result, and if viability is 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.