×
ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%
ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%
ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%
×

ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%

Color: Blue, Yellow, Green or as requested
Size: 17.5X9.5cm,
Material: SBPP,MB,SBPP
Sales Model: Wholesale
MOQ: 200000PCS
Style:Earloop

Product: ASTM Level 3 Surgical Face Mask Disposable Non Woven FDA 510K BFE 99%

Styleearloop
Size17.5*9.5cm
Material3ply: SBPP,MB,SBPP
CertificationFDA 510K, CE, ISO13485
Structurewithout face visor
Typewithout soft foam
Nose clip
double wire

Specification:

1.Conform to FDA 510K (No:K101000).

2.Glass fiber free and latex free.

3.Breathing Resistance (Delta P)<6.0.

4.Bacterial Filtration Efficiency (BFE%) >99%

5.Particle Filtration Efficiency(PFE%)>99%.

6.Synthetic Blood Penetration Resistance: 160mmHg.

Packing: 

Normal PackingQTY
(pc)
Carton Size
(cm)
N.G
(kg/ctn)
W.G
(kg/ctn)

Prodution

Time

(day)
50pcs/box
40boxes/ctn
200,00052X40X367.58.510
700,000
(1X20GP)
15
1,440,000
(1X40GP)
20
1,720,000
(1X40HQ)
20

Remark: 


Production time is based on quantity and the time of order confirmation.


Shipping Port: Shanghai or Wuhan.

Packing Picture:

Product storage.jpg

Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.


face mask .jpg

face mask application.jpg


Wellmien Performance for Surgical Face Mask ASTM Level 3 Non Woven FDA510K:

Standard Class

Breathing Filtration Efficiency (BFE)

Breathing Resistance (mmH20/cm2)

Splash Resistance
(mmHg)

Particulate Filtration Efficiency (PFE)

FDA 510K

 ASTM F 2100

Level 3

>99%

< 6,0

160

>99%


FDA 510 K Requirements:


MEDICAL FACE MASK TESTS AND REQUIREMENTS

U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS
Test ItemASTM F2100-19
Level 1Level 2Level 3
Barrier TestingBFE%
ASTM F2101
≥95≥98
PFE%
ASTM F2299
≥95≥98
Synthetic Blood
ASTM F1862
Pass at 80mmHgPass at 120mmHgPass at 160mmHg
Physical TestingDifferential Pressure5.0 mmH2O/cm³6.0 mmH2O/cm³
Safety TestingFlammablility
16 CFR Part 1610
Class 1 (≥ 3.5 seconds)
Microbial Cleanliness
ISO 11737-1
Not required
Biocompatibility
ISO 10993
510 K Guidance recommends testing to ISO 10993
Sampling
ANSI/ASQC Z1.4
ISO 2859-1
1. AQL 4% for BFE,PFE, Delta P
2. 32 masks for Synthetic Blood
(Pass=≥29 passing, Fail=≤28 passing
3. 14 masks for Flammability


Workshop.jpg

Keywords

surgical mask FDA 510K surgical mask ASTM Level 3 surgical mask BFE 99% surgical mask fluid resistance surgical Mask nonwoven surgical mask PFE 98% surgical mask breathable surgical mask
×

Contact Us

captcha