ESOUND MEDICAL PROTECTION MASK N95/99 (FILTRATION RATE 99%) GB19083-2010

ESound Medical Device Co. Ltd,  Medical Device Manufacturing
Medical protective mask

Lightweight disposable flat folded mask
Contour fit, Easy breathing or speaking
Material: non-woven and melt-blown cloth, nose clip and mask belt
Executive Standard: GB19083-2010
Multilayer filter protection, Filtration rate>99%
Certificate: CE, FDA, Noish

Single package Sealed in a sterilized environment
Sterile,
Single-use
Aseptic,
Ethylene Oxide Sterilization.
N95/99 Medical Standard
Multilayer filter protection, Filtration rate ≥99%
4 Layers of mask:
1 layer: fungi-proofing Non-woven
2 layer: BFE 99 melt-blown fabric
3 layer: BFE 99 melt-blown fabric
4 layer: Close skin cotton

Specifications and Models:
Duck-mouth, Arched, Folded
Structure and composition:
Nonwovens and polypropylene melt-spraying fabric production, nasal splint, mask belt (Conformity directive (s): 93/42/EEC)

Meet standard GB19083-2010 (filtering capacity up to 99%)
Relevant standard (s):
EN 14683:2019
EN ISO 10993-11:2018

Scope of application:
Applicable to the protection of medical personnel and related personnel against airborne respiratory infectious diseases
Original registration number: 20152640350
Approval date: 13/09/2108
Expiry date: 29/09/2023
Report Number: 202000843
Sample number: 20200431

Filtration efficiency:
When the gas flow rate is under 85L/min, the filtration efficiency of the mask for non-oily particles should meet the requirements in table 1 of the GB19083-2010 Standard
Inspection result: Min before temperature treatment: 99%
Min after temperature treatment: 99%

Air resistance:
When the gas flow rate is under 85L/min, the inhalation resistance of the mask should not exceed 343.2pa(35mmH2O)
Inspection result:
Max: 12mmH2O, Qualified

Synthetic blood penetration:
Spray 2ml of synthetic blood into the mask at 10.7kPa (80mmHg) pressure: No infiltration should occur inside the mask
Inspection result: Meet the requirements
Medical Device Directive 93/42/EEC
EC Declaration of Conformity (Annex VII of Directive 93/42/EEC
EN 14683:2019
EN ISO 10993-11:2018
EN ISO 13485:2016
CE/ISO13485/ISO9001

Additional information