USA FDA 510 K Surgical Mask
Thea-Tex Healthcare (India) Pvt. Ltd.
Product Details
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
Thea-Tex Healthcare (India) Pvt. Ltd., Established in 2005 at Vasai in Maharashtra, is leading Exporter, Manufacturer, Supplier of Surgical Dressings & Disposable in India. Thea-Tex Healthcare (India) Pvt. Ltd. is one of Trade India's verified and trusted sellers of listed products. With their extensive experience of supplying and trading Ear Loop Surgical Face Mask, Thea-Tex Healthcare (India) Pvt. Ltd. has made a reputed name for themselves in the market with high quality Ear Loop Surgical Face Mask, Adult Diaper, Visor Mask etc. 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
- ANNUAL TURNOVER Rs 10 Crores
- CERTIFICATION ISO 9001:2000
- WORKING DAYS Monday To Sunday
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