Fda regulate latex and nitrile gloves examination and surgical as medical devices.
Fda approved nitrile gloves manufacturers in vietnam.
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.
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.
Vietnam viet glove corporation viet glove jsc vietnam nitrile gloves manufacturer white glove vietnam detailed instruction for successful contracting with gold garment.
Class i with approved 21 cfr 820 fda 510 k.
The table includes the city state location of the supplier and the type of company.
Table 1 below presents the top ten small to mid sized suppliers of nitrile gloves located in the u s.
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.
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.
Top glove vietnam v gloves viet glove corp.
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.
Companies are listed alphabetically.
Prepare the purchase order documents included.