TGA-M-003 3 PLY Disposable Face Mask Type 2R

Product catalog summary

Product Description: The 3 Ply Disposable Face Mask is designed with ear loops, a nose clip, and is made from PP non-woven fabric, PP melt-blown, and non-woven fabric. It provides isolation and protection through filtration, with the nose clip enhancing protection for the mouth and nose.

Storage and Disposal: Masks should be stored in dry, clean conditions in their original packaging, away from sunlight, high temperatures, and solvent vapors. The shelf life is 3 years if stored properly. Damaged or contaminated masks should be replaced and disposed of according to local regulations.

Warnings and Limitations: Ensure the mask is suitable for the intended application and fitted correctly. The mask should not be altered or modified. The employer is responsible for determining the mask's suitability for specific situations. Information may be revised at any time.

Intended Use: Suitable for clinical and laboratory settings to protect against microorganism and bodily fluid transfer in low-risk situations. Not intended for high-risk surgical procedures. Typical applications include protection against blood, bodily fluids, and in clean room environments.

Key Features: The mask is tested and CE approved to EN 14683+AC 2019 and ISO13485:2016 standards. It has a bacterial filtration efficiency (BFE) of >98%, splash resistance pressure of 16, differential pressure (PA/cm2) of <60, and microbial cleanliness (cfu/g) of <30. It features comfortable ear loops, is latex-free, and contains no natural rubber latex components.

Approvals and Protection: The mask meets medical device requirements and is CE approved under the Medical Devices Regulation, 93/42/EEC.

Packaging: The masks are packaged with 50 pieces per box and 40 boxes per carton.

Manufacturer Information: TGA Medikal ve Dış Ticaret A.Ş., located in Istanbul, Turkey. Contact: +90 212 264 06 57-58, www.tgamedikal.com

Catalog excerpts

TGA-M-003 3 PLY Disposable Face Mask Type 2R-1

3 PLY DISPOSABLE FACE MASK Disposable face mask is composed of ear loops, nose clip and ear loops, made of PP non-woven fabric, PP melt-blown, and non-woven Fabric. Plays the role of isolation and protection through ﬁltration, the ﬁxed nose clip enhance the protection,of the mouth and nose. 3 PLY Disposable Face Mask Type 2R TGA-M-003 KEY FEATURES . Tested and CE approved to EN 14683+AC 2019 Medical face mask-Requirements and test methods and ISO13485:2016 Medical Devices- Quality management systems . Bacterial ﬁltration Efficiency ( BFE ) >98. . Splash Resistance Pressure 16. . Differential Pressure (PA/cm2) <60. . Microbial cleanless (cfu/g) <30 . Comfort ear loops allow for easy donning and doffing. . Provided latex-free and plexiglass. . Contains no components made from natural rubber latex. APPROVALS AND PROTECTION 3 ply Face Masks fulﬁls the requirements for medical devices. CE approved under Medical Devices Regulation, 93/42/EEC STORAGE AND DISPOSAL . Store in dry and clean conditions in original packaging, away from direct sunlight, sources of high temperature, and solvent vapours. . Expected shelf life is 3 years from the date of manufacture when stored as stated. . Replace garment if damaged, heavily contaminated of in accordance with local work practice or regulations. . Handle and dispose of contaminated garments with care and in accordance with applicable regulations. WARNING AND LIMITATIONS Make sure that the product is suitable for the application and ﬁtted correctly. Product must never be altered or modiﬁed. Final determination as to the suitability of these products for a particular situation is the employer’s responsibility. This information is subject to revision at any time. PACKAGING 50 pcs per box. 40 boxes per carton. INTENDED USE . For use in clinical and laboratory settings. . Intended to protect from the transfer of microorganisms and bodily ﬂuids in low or minimal risk patient isolation situations. . Not intended for high risk surgical procedures, or where the risk of contamination is high. . Typical applications may include blood, bodily ﬂuids and environmentally controlled clean room applications. TGA MEDİKAL VE DIŞ TİCARET A.Ş. Sultan Selim Mah. Behçet Sok. Büyükdere İş Mrk. No:4 D:5 Kağıthane/İstanbul-TURKEY T: +90 212 264

Open the catalog to page 1

All TGA Medical catalogs and technical brochures

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

Brand list