Bērnu ķirurģiskā maska IIR tips ar ausu gumijām B-Good Kids

Bērnu sejas maska ar gumijām Tips IIR, nesterila. Mitrumu izturīga. Nesatur lateksu. Baktēriju filtrācija ≥ 98%.

Ražotāja tehniskā specifikācija.

1. DESCRIPTION OF PRODUCT :
B-good 3 layer surgcal mask, can be fit accordng to each face measures and shapes, flexble and can be used wthout dsturbng the soft structure. Ar permeable and lets breathng easly. Non- rrtatng. Provdes protecton aganst bactera. 99,9 % bactera filtraton effice ncy.

2. QUALITY SYSTEM OF MY TICARET VE MEDIKAL :
Honnes Sağlık ve Endüstryel Ürünler A.Ş has been manufacturng ts products wth the qualty systems as gven below;
EN ISO 9001:2015 Qualty Assurance System
EN ISO 13485:2016 Qualty Assurance System-Medcal Devces

3. PRODUCT IDENTIFICATION AND RECOMMENDED USE :
The product s made by non wowen fabrc. The product’s composton s polypropylene and does not ncludes latex. The product s breathable and has no specal personal on envronmental hazards. The product s made automatcally n hygenc condtons. The product prevents the potental reactons between all knd of lquds and partcles, mcroorgansms.
Size
175 mm 95 mm 70 mm

4.1.Materal Safety Data Sheet (MSDS)

4.1.1. Composton:

Idendficaton of the type of nonwoven product.
Thermobonded Nonwoven by calenderng process
Polypropylene CAS No: 25085-53-4 spunbond–meltblown modficaton
Web surface treatment – Concentraton above 1°/0 – *No.
Bnder – *No
Addtves – Yes.
May contan color pgments f the product s n color. Whte color may contan T02.
Other major components-*No
Chemcals (n relevant concentraton) that are n lst of dangerous substances – *.No

4.1.2. Hazards dentficaton
Under normal condtons of use and handlng, ths product s not expected to create any health or safety hazards.
Accdental thermal decomposton or meltng state can present hazards.

4.1.3. Frst-ad measures
Undernormal condton ;
Inhalaton – No specfic measure to be taken
Skin contact – No specfic measure to be taken
Eyes contact – No specfic measure to be taken
Ingeston – No specfic measure to be taken

4.1.4. Fre fightng measures

Sutable extngushng meda;Water spray, dry chemcal or CO2 extngusher. No specal procedures are expected to be necessary for ths product. Normal fire fightng procedures should be followed to avod nhalaton of smoke and gases
Extngushngmeda not to be used – None
Specal exposure hazards – For flammable and toxc fumes aswell as skn contact wth molten materals see Ş 10
Specal protectve clothng for fire-fighter – None. It s recommended that fire-fighters should wear full protectve clothng ncludng self contaned breathng apparatus.

4.1.5. Accdental release measures

Personal Precautons:Avod dust formaton. Forms slppery surface.

4.1.6. Handlng and storage

Keep n a dry and closed area wth the orgnal packng. The packages have to be handled so that they can not break and to be arranged as to prevent them from fallng. The goods shall be handled wth good ndustral hygene and safety practce.

4.1.7. Exposure controls / personal protecton

No specfic measures. Handle n accordance wth good ndustral hygene and safety practce. Use of safety glasses and face mask s recommended f dust s formed durng applcaton.

4.1.8. Physcal and chemcal propertes

Aspect………………………………………………………..Sold, n rolls or sheets
Appearance (the colour of the product as suppled)………….Normally whte f not a specfic color s mentoned.
Odour……………………………………………………….Practcally odorless
Ph……………………………………………………………Not applcable
Bolng pont/bolng range…………………………………Not applcable
Meltng pont/meltng range………………………………..(Polypropylene 165°C (330°F) )
Decomposton temperature……………………………….. > 260°C (500°F)
Flash pont…………………………………………………..Not applcable
Flammablty ………………………………………………..Not easly flammable
Explosve propertes…………………………………………Not applcable
Oxdzng propertes…………………………………………Not applcable
Vapourpressure………………………………………………Not applcable
Statc electrcty……………………………………………..The product can develop and/or accumulate statc electrcty, (.e. by rubbngor frcton) Solublty…………………………………………………….Mater nsoluble – fat nsoluble
Partton coefficent……………………………………………Not applcable

4.1.9. Stablty and reactvty

TECHNICAL FILE B-good Surgcal Mask

The product s stable at room temperatures and does not decompose or self react when handled and stored under prescrbed condtons. Toxc fumes can be generated under thermal decomposton.

4.1.10. Toxcologcal nformaton

No toxc reacton known under normal condtons. Partcularly, no case of coetaneous senstsaton or of mutagenc / carcnogenc actvty s known. Underdecomposton condtons, toxc fumes and contamnated water.

4.1.11. Ecologcal nformaton

For transportaton, storage and normal use no toxcologcal effect known. The fabrc wll not degrade bologcally n short term.

4.1.12. Dsposal consderatons

As non hazardous sold waste, dependng on local regstraton, nonwovens can be dsposed of through recyclng, landfill.

4.1.13. Transport nformaton

Not classfied as dangerous for transport.

4.1.14. Regulatory nformaton

Not classfied as dangerous n complance wth Turkey and European regulaton regardng classfyng, packagng and labelng of hazardous substances and products.

5. PERFORMANCE REQUIREMENTS OF FINISHED PRODUCTS
We declare our products comply wth EN 14683:2019 as Type IIR.

6. INSTRUCTIONS FOR USE
6.1. Intended Use:
Surgcal mask s ntended to be worn by medcal personnel durng surgcal or other medcal procedures to protect both the patent and the operatng personnel from transfer of mcroorgansms, body flud and partculate materal transfer.
Reduces exposure to blood and body fluds. Mnmzes patent contamnaton to exhaled mcroorgansms. Ths product s ntended for use n nfecton control practces.
6.2. Techncal Specficatons:
Non-rrtatng, Flud Resstant, Three Ply constructon.
3 pleats of folds to allow the user to expand the mask so t covers the area from the nose to the chn. Mask should be secured wth an ear loop to be placed behnd the ears.

The surgcal mask’s three-ply layers work as follows:

The outer layer repels water, blood, and other body fluds. The mddle layer filters certan pathogens.
The nner layer absorbs mosture and sweat from exhaled ar.

6.3. Donnng The Mask:

– Before puttng on the mask, wash your hands for at least 20 seconds wth soap and water, or rub your hands together thoroughly wth alcohol-based hand santzer.
– Check for defects n the face mask, such as tears or broken loops.
– Poston the colored sde of the mask outward.
– If present, make sure the metallc strp s at the top of the mask and postoned aganst the brdge of your nose.
– Ear loops: Hold the mask by both ear loops and place one loop over each ear.
– Mold the bendable metallc upper strp to the shape of your nose by pnchng and pressngdown on t wth your fingers.
– Pull the bottom of the mask over your mouth and chn.
– Be sure the mask fits snugly.
– Don’t touch the mask once n poston.
– If the mask gets soled or damp, replace t wth a new one.!! Do not;
- – touch the mask once t’s secured on your face, as t mght have pathogens on t
- – dangle the mask from one ear
- – hang the mask around your neck
- – reuse sngle-use masks.If you have to touch the face mask whle you’re wearng t, wash your hands first. Be sure to also wash your hands afterward, or use hand santzer.

6.4.

Doffing The Mask:

Before you take off the mask, wash your hands well or use hand santzer.

Avod touchng the mask tself, as t could be contamnated. Hold t by the loops, tes, or bands only.

Carefully remove the mask from your face once you: unhook both ear loops. Holdng the mask loops dscard the mask by placng t n a covered trash bn. After removng the mask, wash your hands thoroughly or use hand santzer.

FIRE FIGHTING MEASURES :

TECHNICAL FILE B-good Surgcal Mask

Sutable Fre Extngushers and Methods:

Water spray, foam, carbon doxde or dry chemcals. A sudden nterventon should be made to

the fire ext wthout any possble danger. If the materal s melted, do not apply drect water flow. Use fine water spray or foam.

8. DISPOSAL CONSIDERATIONS :
Dspose of accordng to the Regulaton on Control of Hazardous Wastes.

8. USEAREAS :
Hosptals, medcal companes, doctor offices, laboratores, food manufacturers, cleanng

companes and work places where the hygnec areas are necessary.

9. SHELF LIFE : 5 Years

10. Capable of beng stored contnuously n ambent temperature of 10 to 35 deg C and relatve humdty of 15 to 55%. Capable of operatng contnuously n ambent temperature of 10 to 35 deg C and relatve humdty of 15 to 55%.

It s recommended that surgcal face masks should be stored n ther orgnal contaners and should be stored away from drect sunlght, heat sources and lquds, ncludng chemcals. The area should be clean and should protect the masks from contamnaton. Never store t n a purse or pocket.

11. SAFETY INFORMATION :

Pay attenton to the warnngs.
It s not sterle.
It s for sngle use only.
Do not use f the package s damaged.
Do not use the product after expraton date.

Izcelsmes valsts	Turcija
Ražotājs	Honnes Saglik Ve Endustriyel Urunleri A.S.
Produkta izmērs	175mm x 95mm – ausu cilpas garums 70mm
Vienību skaits iepakojumā	10
Sertifikācija	CE marķējums, direktīva 93/42/EEK, EK atbilstības deklarācija, EN14683