Usa Fda 510 K Surgical Mask
WhatsAppGet Latest PriceThea-Tex surgical masks already meet and exceed the performance
requirements of ASTM F2100 US Standard and the p...View Product Details
Product Overview
Key Features
Thea-Tex surgical masks already meet and exceed the performance
requirements of ASTM F2100 US Standard and the process is on for FDA
notification, registration and listing in order to market surgical
masks in the US.
In addition to the performance requirements for
marketing surgical masks in Europe there are additional test parameters
pertaining to flammability and particle filtration efficiency. FDA
guidance suggests Biocompatibility testing such as cytotoxicity,
sensitization and irritation testing which is being followed.
The US standards have three classifications for low barrier, moderate barrier and high barrier, which Thea-Tex masks meet.
Company Details
Focusing on a customer-centric approach, Thea-Tex Healthcare (India) Pvt. Ltd. has a pan-India presence and caters to a huge consumer base throughout the country. Buy Surgical Dressings & Disposable in bulk from Thea-Tex Healthcare (India) Pvt. Ltd. at Trade India quality-assured products.
Business Type
Exporter, Manufacturer, Supplier
Employee Count
100
Establishment
2005
Working Days
Monday To Sunday
Certification
ISO 9001:2000
Seller Details
Thea-Tex Healthcare (India) Pvt. Ltd.
Rating
4
Marketing - Head
Mr. Anand Singh
AddressView on Map
23-M, Mangal,Anand Mangal Industrial Estate, Opp. IPOL Industries, Sativali Road, Waliv Phata, Vasai (E), Vasai, Maharashtra, 401208, India
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