(76 days)
The Rostan Scented and Unscented Biodegradable Plastic Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Rostam plastic scented and unscented biodegradable applicator tampons are being submitted to obtain clearance for a new material applicator. They are menstrual tampons used to absorb menstrual fluid. These Tanıpons will be provided with 4 absorbencies, light, regular, super and super plus.
These Tampons are made from rayon and/or cotton (as the absorbent material) polymeric overwrap, cotton/polyester sewing thread and cotton cord.
The provided text is a 510(k) summary for a menstrual tampon device. It discusses the device's substantial equivalence to previously marketed tampons and includes information about performance testing related to biocompatibility and absorbency. However, it does not describe any acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria. Therefore, I cannot extract the requested information.
The document pertains to a traditional medical device (menstrual tampons) and not an AI/ML powered device. The questions in the prompt are specifically geared towards the evaluation of AI/ML medical devices.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).