(199 days)
The Patient 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 a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).
Here's an analysis of the provided information, focusing on the requested aspects.
1. A table of acceptance criteria and the reported device performance
Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.
Acceptance Criteria and Reported Device Performance
| No. | Name of the Test Methodology | Standard | Acceptance Criteria | Reported Device Performance and Remarks | Pass/Fail |
|---|---|---|---|---|---|
| 1 | Tests For Skin Sensitization | ISO 10993-10:2021 | Skin Sensitization Test: Grades less than 1, otherwise sensitization. | Fern Green, Blue Sky, Midnight Black: No sensitization response was observed in control and treatment group animals. Classified as "non-sensitizer". | Pass |
| 2 | Tests For Skin Irritation | ISO 10993-23:2021 | Skin Irritation Test: Primary irritation index 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). (Implied goal is negligible or slight irritation). | Fern Green, Blue Sky, Midnight Black: No abnormality detected in animals. Classified as "non-irritant". | Pass |
| 3 | In Vitro Cytotoxicity | ISO 10993-5:2009 | Cell 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.