Fda Approved Nitrile Gloves Manufacturers In Vietnam

Class i directive mdd 93 42 eec.

Fda approved nitrile gloves manufacturers in vietnam.

Class i with approved 21 cfr 820 fda 510 k. Loi sent to gold garment company clearly specify the needs of the buyer. Prepare the purchase order documents included. Nitrile examination glove is a disposable device intended for medical purposes that are worn on the examiner s hand to prevent contamination between the patient and examiner.

United states of america usa. Companies are listed alphabetically. Top glove is considered one of the largest glove manufacturers in the country employing more than 18 000 staff with an annual production capacity of over 73 4 billion pairs. According to the company they occupy 26 of the world market share for rubber gloves in 2019 exporting to more than 2 000 customers from 195 countries worldwide.

Fda regulate latex and nitrile gloves examination and surgical as medical devices. Even though the gloves are class 1 device it requires fda 510k clearance medical device establishment registration and device listing to market in the usa powdered gloves are not allowed to market in the usa for medical purpose. Nitrile glove fda ce by vietnam manufacturer find complete details about nitrile glove fda ce by vietnam manufacturer gloves nitrile glove nitrile gloves from gloves supplier or manufacturer boowoo a member company limited. Table 1 below presents the top ten small to mid sized suppliers of nitrile gloves located in the u s.