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FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask

Min Bestellmenge : 30 Kartons Preis : Verhandelbar
Verpackung Informationen : 50pcs/Box, 40 Boxen/Karton oder 10pcs/Polybag, 10 Bags/Karton Lieferzeit : Spitzenzeiten: über 1 Monat, Ausfallzeiten: innerhalb von 1 Monat
Zahlungsbedingungen : L/C, D/A, D/P, T/T, Western Union, MoneyGram Versorgungsmaterial-Fähigkeit : Herum 50 x 40' HQ/Month
Herkunftsort: Xiantao, Hubei Markenname: JINLIANG or OEM
Zertifizierung: ASTM F2100 Level-3 Modellnummer: A-31-L3

Detailinformationen

Stil: Earloop, verstellbare Nasenclip, flache Falten Größe: 17.5x9.5cm
Schicht: drei Schichten Farbe: Blau
Sterilität: Nicht steril ASTM F2100 Level: Level-3
BFE: > 99% Verwenden: Einzelne Verwendung
Verpackung: 50pcs/Box, 40 Boxen/Karton oder 10pcs/Polybag, 10 Bags/Karton
Hervorheben:

FDA standard disposable face mask

,

three-layer blue face mask

,

earloop disposable face mask

Produkt-Beschreibung

Disposable Face Mask (ASTM F2100 Level-3)

 

 
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
 
 
FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 0
FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 1

 

Layer three layers
Style  flat pleated, earloop, adjustable nose clip
ASTM F2100 Level Level-3
Color  blue
Sterility non-sterile
Size  17.5x9.5cm
Packaging  50pcs/box, 40boxes/carton or 10pcs/polybag, 10bags/carton
Applications operation, dental clinic, 
OTC use  Yes

 

 

Product Test Data:

ASTM F2100 Level Level-3
Biocompatibility ISO10993

Fluid Resistance Performance

ASTM F1862

32 out of 32 pass at 160 mmHg

Particulate Filtration Efficiency

ASTM F2299

98.98%

Bacterial Filtration Efficiency

ASTM F2101

99.9%

Differential Pressure(Delta P)

EN 14683 Annex C

5.54mmH2O/cm2

 

 

About Us: 

 

Hubei TDL Group is made of Hubei Orient International Trading Corporation and Ammex-weida(Hubei) Health and Safety products Co.,Ltd. We specilize in the design,manufacturing and sales of disposable medical products and PPE products for more than 20 years. 

 

We established in 2003,covering 65,000 square meters. We are a group of more than 500 individuals. Ammex-weida is equipped with a medical and industrial laboratory in class 10000, clean room workshops in class 100000 for sterile medical devices and all kinds of disposable products. 

 

Our group has more than 20 individuals for QC quality control, laboratory and inspection.Our laboratory could do tests for face masks such as particulate filtration efficiency, differential pressure, Synthetic blood penetration,Tensile test for earloop,flammability test,microbial cleanliness,splash resistance,sterile test, ethylene oxide residue etc.And also we could do tests for coveralls such as hydro-static pressure, Repellency by liquids, Resistance to Penetration by liquids,Surface Resistance, Resistance to Ignition,filtering efficiency,Puncture Resistance,Tensile strength,static decay period,sterile test, ethylene oxide residue etc.

 

FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 2

 

We utilizes a complete quality management system ISO9001, ISO13485. We care about human rights and we are certified by human right agency of SEDEX. Ammex-weida has medical device license for class I and II. Our products are certified with CE, FDA, UKCA. Our medical face masks passed through Nelson's test. Our medical face masks are conform to EN14683 type II and type IIR for Europe market, ASTM level 3 510K for North America and the national standard YY0469 and YY0969 for China market. Our category III protective coveralls are complied with new European PPE Regulations (EU)2016/425. They are classified to type 3/4/5/6 and 3B/4B/5B/6B.

 

FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 3

 

 

Our Product Lines:

 

1. Face mask: disposable nonwoven face mask, surgical facemask, active carbon face mask, dust mask, N95 mask, paper mask, etc.

2. Surgical gown: surgical gown, PP/PE gown, isolation gown, SMS surgical gown, sterile surgical gown, patient gown, etc.

3. Coverall:disposable PP coverall, PP/PE coverall, SMS coverall , Microporous coverall (with/without hood, with/without boots, any color.)

4. Lab coat: disposable lab coat, PP lab coat, SMS lab coat, Microporous lab coat, vistor coat, PP/PE/Tyvek apron.

5. Caps: doctor caps, bouffant caps, round caps, clip caps, non woven caps

6. Sleeve/shoe cover: PP sleeve cover, pe sleeve cover, SMS sleeve cover, Microporous sleeve cover, non skid shoe cover, PE/CPE shoe cover

7. Beauty Products- Nonwoven kimono, mantle, hair band, slipper, PE shower cap and so on.

 

FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 4

FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask 5

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