(79 days)
The Disposable nitrile 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 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 provided document describes the non-clinical performance testing for "Disposable Nitrile Gloves" (K212009) to demonstrate substantial equivalence to a predicate device (K171422).
Here's the breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|-----|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin sensitization. | Grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assesses possible contact hazards from chemicals released from medical devices, that may produce skin irritation. | Primary irritation index of 0-0.4 for negligence. | Primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| 3 | ISO 10993-5:2009 (Cytotoxicity) | Assesses the in vitro cytotoxicity of medical devices. | Viability percentage (Viab.%) of the 100% extract of the test article is the final result. 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.