Schutzkittel

  • Produkt Nr.: FSB-110
  • Produktname: PP + PE 60GSM
  • Test Report: CNAS
  • Art: nicht steriler Schutzkittel
  • Material: PP + PE(60g)
  • Geprüft gemäß:
    GB/T 7573-2009 ISO3071:2005
    GB/T 2912. 1-2009 ISO 3071:2005
    GB/T 2912. 1-2009 ISO 14184-1:1998
    GB/T 3822-2013 ISO 105-E04:2013
    GB/T 5713-2013 ISO 105-E01:2013
    GB/T 3920-2008 ISO 105-X12:2001
    GB/T 18401-2010 6.7
    GB/T 17592-2011
Preis pro VE
Stückzahl VE Express
ab 10.000 3,6213 €
ab 25.000 3,6089 €
ab 50.000 3,5785 €
ab 75.000 3,5493 €
ab 100.000 3,5490 €

 

Protective Gown  Protective Gown

 

  • Produkt Nr.: FSB-111
  • Produktname: PP + PE 40GSM
  • Test Report: CNAS
  • Art: nicht steriler Schutzkittel
  • Material: PP + PE(40g)
  • Geprüft gemäß:
    EN ISO 811:2018
    EN ISO 11737-1:2018
    EN ISO 811:2018
    EN ISO 22612:2005
    EN ISO 22610:2006
    EN ISO 9073-10:2004
    EN ISO 13938-1:1999
    EN 13795-1:2019
    EN 29073-3:1992
Preis pro VE
Stückzahl VE Express
ab 10.000 2,8585 €
ab 25.000 2,8429 €
ab 50.000 2,8304 €
ab 75.000 2,8283 €
ab 100.000 2,8262 €

 

Protective Gown  Protective Gown

 

  • Produkt Nr.: FSB-112
  • Produktname: PP + PE 35GSM
  • Art: nicht steriler Schutzkittel
  • Material: PP + PE(35g)
Preis pro VE
Stückzahl VE Express

 

Protective Gown

 

  • Produkt Nr.: FSB-113
  • Produktname: Schutzkittel
  • Test Report: TÜV Rheinland
  • Art: nicht steriler Schutzkittel
  • Material: PP(25g) + PE(15g) + Laminat
  • Anzahl je Einzelverpackung: 100 Stück
  • Größen:
    M - Umfang 45-65cm, Körperlänge 160-170cm
    L - Umfang 60-75cm, Körperlänge 165-180cm
    XL - Umfang 65-95cm, Körperlänge 175-195cm
Preis pro VE
Stückzahl VE Express
ab 10.000 2,29 €
ab 25.000 2,03 €
ab 50.000 1,83 €
ab 75.000 1,75 €
ab 100.000 1,64 €

 

Protective Gown  Protective Gown

Protective Gown

Protective Gown

Protective Gown

 

  • Produkt Nr.: FSB-114
  • Produktname: PP + PE 65GSM
  • Zertifizierung: TÜV Süd + CE
  • Art: nicht steriler Schutzkittel
  • Material: PP + PE(65g)
  • Größen:
    S - Länge 183cm
    M - Länge 188cm
    L - Länge 193cm
    XL - Länge 199cm
    XXL - Länge 203
    XXXL - Länge 211cm
  • Geprüft gemäß:
    EN 14605:2005+A1:2009
    EN 14126:2003/AC:2004
    EN ISO 12947-2:2016
    EN ISO 7854:1997
    EN ISO 9073-4:1997
    EN ISO 13934-1:2013
    EN ISO 13935-2:2014
    EN ISO 17491-3:2008
    EN ISO 17491-4.2008
    EN 13274-4:2001
    EN 14325:2018
    EN 863:1995
Preis pro VE
Stückzahl VE Express
ab 10.000 12,3356 €
ab 25.000 12,3261 €
ab 50.000 12,3200 €
ab 75.000 12,3180 €
ab 100.000 11,2886 €

 

Protective Gown

Protective Gown

Protective Gown  Protective Gown

 

General information:

Comparison of Medical Protective Clothing Standards

The result of comparison between China's mandatory national standard GB 19082-2009 technical requirements for disposable protective clothing for medical use and the EU standard (EN 14126) is as follows. This result is summarized through the materials of standard comparison provided by Medical Device Standard Management Center of China Medical Products Administration, Science and Technology Development Department of China National Textile Industry Federation, National Technical Committee for Personal Protective Equipment Standardization and other relevant parties.

For scope of application

EN 14126 applies to reusable anti-virus protective clothing.

GB 19082 applies to medical disposable protective clothing for medical personnel who come into contact with potentially infectious patients' blood, body fluids, secretions and airborne particles to provide barrier and protection.

For physical properties of fabric

EN 14126 refers to EN 14325, Chemical Protective Clothing Chemical Protective Clothing Materials, Seams, Joints and the Test Method and Properties Classification of Components. EN 14325 requires that protective clothing should be tested and classified according to the fabric test methods and fabric performance classification system determined by the standard.

GB 19082 specifies two indexes such as elongation at break and fracture strength. Other indexes such as wear resistance, flexural resistance, flexural resistance (-30℃) and tear are not specified.

For barrier properties of fabric:

EN 14126 mainly refers to international standard such as ISO 16603, ISO 16604, ISO 26610, ISO 26611 and ISO 26612. EU standard specifies the classification requirements in five aspects including anti-synthetic blood penetration, anti-blood-borne pathogen (Phi-X174) bacteriophage contaminated liquid pressure penetration test, anti-wet microbial penetration test, anti-microbial aerosol test, and anti-dry microbial test.

GB 19082 mainly specifies the requirements of the water resistance test, water testing, particle filtration efficiency and moisture permeability.

For overall clothing performance:

EN 14126 mainly specifies three indicators, namely, overall clothing performance test, joint strength and skin irritation, among which the overall clothing performance refers to relevant international standards and EU standards such as EN466. They are divided into protective suits against liquid aerosol and solid particles, liquid dense protective suits (Type3), spray dense protective suits (Type4), protective suits against solid particles (Type5), and protective suits against slight chemical liquid splash (Type6).

GB 19082 specifies six indicators, including requirements for microbial indicators, sterilization requirements, residual ethylene oxide, antistatic property, electrostatic attenuation and skin irritation.

Comparison of Key Technical Requirements from EN 14126:2003 and GB 19082-2009

Standard Number

GB 19082-2009

EN 14126:2003

Standard Name

Technical Requirements for Disposable Protective Clothing for Medical Use

Protective Clothing - Performance, Requirements and Test Methods for Anti-virus Protective Clothing

Scope

The standard standardizes the requirements for disposable protective clothing for medical use. This standard is applicable to medical disposable protective clothing for medical personnel who come into contact with potentially infectious patients' blood, body fluids, secretions and airborne particles to provide barrier and protection.

Applications: medical disposable protective clothing

The standard standardizes the requirements and test methods for reusable, limited-use anti-virus protective clothing. The standard does not apply to protective clothing worn by first-line surgical personnel or surgical orders placed on the patient's body to prevent cross-contamination during surgical intervention.

Applications: Anti-infective-substance protective clothing

Technical Terms

Index Requirements

Test Methods

Index Requirements

Test Methods

Physical Properties of Fabric

Abrasive Resistance

None

 

Mechanical and flammability requirements: materials shall be tested and classified in accordance with the test methods and performance classification system standardized under the relevant provisions of pr EN 14325.

Flexing

Resistance

None

 

Flexing

Resistance at

-30

(Optional)

None

 

Tear

Resistance

None

 

Elongation at Break

Key parts should not be less than 15%

GB/T 3923.1-1997

Fracture Strength

Key parts should not be less than 45N

GB/T 3923.1-1997

Barrier Properties of Fabric

Impermeability Test

The hydrostatic pressure of key parts should be ≥1.67kpa

GBT 4744-1997

None

Water Test

≥Level 3

GBT 4745-1997

None

Particle

Filtration

Efficiency

The filtration efficiency of Nacl at key parts and joints should be no less than 70%

Article 5.7 of

GB 19082-2009

None

Moisture

Transmission

≥2500g/(m2·d)

Method A of GB/T 12704-1991

None

Resistance to

Synthetic

Blood

Penetration

Level 1 (0kPa)

Level 2 (1.75kPa)

Level 3 (3.5kPa)

Level 4 (7kPa)

Level 5 (14kPa)

Level 6 (20kPa)

Should not≤Level 2

Annex A to

GB 19082-2009

Level 1 (0kPa)

Level 2 (1.75kPa)

Level 3 (3.5kPa)

Level 4 (7kPa)

Level 5 (14kPa)

Level 6 (20kPa)

Classification according to actual test results.

ISO 16603

Pressure penetration test of contaminated liquid against blood-borne pathogen (phi-x174) bacteriophage

None

 

Level 1 (0kPa)

Level 2 (1.75kPa)

Level 3 (3.5kPa)

Level 4 (7kPa)

Level 5 (14kPa)

Level 6 (20kPa)

Classification according to actual test results.

ISO 16604

Resistance to

Moisture

Microbe

Penetration

None

 

Level 1 (≤15min)

Level 2 (15<t≤30min)

Level 3 (30<t≤45min)

Level 4 (45<t≤60min)

Level 5 (60<t≤75min)

Level 6 (t>75min)

T is the breakthrough time

ISO 26610

Anti-microbial Aerosol Test

None

 

Level 1(1<log≤3)

Level 2(3<log≤5)

Level 3(log>5)

Log is penetration

ISO 26611

Anti-dry

Microbe Test

None

 

Level 1(2<log cfu ≤3)

Level 1(1<log cfu ≤2)

Level 3(log cfu ≤1)

Log cfu is the penetration index

ISO 26612

Overall Clothing Performance

Overall

Clothing

Performance

Test

None

 

Specific requirements refer to other EN standards:

—— Type 1 EN 943-1 (EN943-2 for emergency team (ET) "airtight" chemical protective clothing)

—— Type 3 EN 466

—— Type 4 EN 465

—— Type 5 ISO 13982-1

—— Type 6 EN 13034

—— Partial body protection EN 467

Seam Strength

None

 

EN 14325

Microbiological Index Requirements

There are requirements for bacterial colony detection

Annex B to GB 15979-2002

None

Sterilization Requirements

Sterilized and non-sterilized. If sterilized, the words "sterile" shall be marked on the package

 

None

Residual

Should not exceed

Article 5.13 of

None

Ethylene Oxide

10μg/g

GB19082-2009

 

Skin Irritation

The primary stimulus score should not exceed 1

Article 5.11 of GB19082-2009

Article 4.3 of EN14126 requires that materials and designs used shall not cause skin irritation or adverse health effects.

Antistatic Property

The electric quantity of protective clothing should not exceed

0.6μC/piece

Article 7.2 of GB/T 12703-1991

None

Static Decay

The static decay time of protective clothing should not exceed 0.5s.

Article 5.10 of GB19082-2009

None

 

Note: The comparison provided is only technical information based on text comparison and cannot be used as a legal basis for the foreign party to choose Chinese products.