(149 days)
A powder-free 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.
The proposed device is a disposable device intended for over the counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. Gloves are not made with natural rubber latex. The glove color is cool blue.
This device submission (K122696) is for Powder-Free Nitrile Examination Gloves (Cool Blue). It is a medical device designed to prevent contamination between patients and examiners. The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards for patient examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance Results Summary |
|---|---|---|
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10 | Gloves are non-irritating. (Meets requirements) |
| Guinea Pig Maximization | ISO 10993-10 | Gloves do not display any potential for sensitization. (Pass) |
| Physical Characteristics: | ||
| Dimensions | ASTM D6319 | Meet requirements |
| Physical Properties | ASTM D6319 | Meet requirements |
| Freedom from Holes | 21 CFR 800.20 & ASTM D6319 | Tested in accordance with ASTM D5151 test method with acceptable results (Meets requirements) |
| Powder Residual | ASTM D6319 (≤2.0 mg/glove for Powder-Free) | Tested using ASTM D6124 test method. Results generated values |
§ 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.