(100 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
This is a 510(k) premarket notification for nitrile examination gloves, not an AI/ML medical device. Therefore, the request for acceptance criteria and study details related to AI/ML performance metrics (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable.
The document assesses the substantial equivalence of the proposed device (Nitrile Examination Gloves) to a predicate device (Powder Free Nitrile Patient Examination Gloves, Blue Color) based on non-clinical testing and comparison of technological characteristics.
Here’s a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of the proposed device with a predicate device, referencing ASTM standards for acceptance criteria. The performance of the proposed device is stated as meeting these requirements.
| Item | Acceptance Criteria (typically from ASTM D6319-19) | Reported Device Performance (K203593) |
|---|---|---|
| Freedom from holes | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19 |
| Physical Properties (before aging) | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19: Tensile Strength: ≥14 MPa, Elongation: ≥500% |
| Physical Properties (after aging) | Meets requirements of ASTM D6319-19 | Meets requirements of ASTM D6319-19 |
| Powder residual |
§ 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.