Factory making Hospital Household Equipment - Disposable Surgical Mask ( 510K) – Jinlian

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Factory making Hospital Household Equipment - Disposable Surgical Mask ( 510K) – Jinlian Detail:

Medical Face Surgical Mask Disposable with Earloop Level1 510k Non Woven Blue Adult Class II ASTMF2100 Level 1
Product Name	ASTM F2100 Level 1 Face Mask
Material	22g SPP+25g Melt-blown+18g SPP
Certificates	CE, TGA, 510K, ISO13485
Standard	510K,ASTM F2100 Level 1 compliant with testing for resistance to synthetic blood penetration
ASTM Level1/2/3	ASTM F2100
Size	17.5×9.5cm
Product type	Head Tie Medical mask, EarLoop Medical Mask
ASTM F 2100 – Level 2 Barrier Protection
Characteristic	Testing Methodology		Acceptable Limits
Bacterial Filtration Efficiency (BFE)	ASTM F2101		BFE @ 3.0 µm large Bacteria ≥ 95%
Differential Pressure (∆P)	MIL-M-36954C		∆P < 4.0 mm of H2O/cm2
Particulate Filtration Efficiency (PFE)	ASTM F2299		PFE @ 0.1 µm large Latex particules ≥ 95%
Fluid Resistance	ASTM F1862		Resistant @ 80mmHg
Textile Flammability	16 CFR 1610		Class I flame spread
Color		Blue/Black/White
Sterile		Sterile/NON Sterile
Package		50pcs/box;2000pcs/ctn
Carton Size		54x49x39cm
Production Capacity		3million/each day
USA Market		Yes, we have all Certificates and Testing Report for USA market for ASTM F2100 Level1/2/3
EU Market		CE Certificates and Testing report, and Local Country Language Package
Independent packaging		Yes, it can be 1pc/bag, 5pcs/bag, and 10pcs/bag
White List		China White List, Italy, Germany, Spain, Norway, Uk…. Government Supplier White List
Applications		Hospital, Laboratory, Home…
Single use		- This product is disposable. Do not use expired products. - After the product is used, it shall be disposed according to the applicable regulations.
Storage		Store away from harmful gases, light, in a ventilated and dry place. Keep away from fire sources and inflammable materials.
Features and usage method		This product is a medical device intended for medical purposes which provides a physical barrier to resist liquid penetration from fluids and other potentially infectious materials. FEATURES AND USAGE METHOD 1. Wash your hands with soap and water or an alcohol-based hand rub. 2. Take out the face mask, put the side with nose clip of mask upward and then put mask belt at both ends of ears. 3. Press the nose clip lightly to make it fit the nose beam, then nose to the mandible to obtain the best protective effect. 5. Avoid touching the mask while using it; if you do, wash your hands. 6. When the mask becomes damp, replace it with a new one. 7. Product usage not inten

Face-Mask-Testing-Requirements
Disposable Surgical Mask ( 510K)

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