Looks like you are not TradeKey.com's Member yet. Signup now to connect with over 9 Million Importers & Exporters globally.
Join Now, its Free |
Book call on your favorite time
Code
       

By Signing Up. I agree to TradeKey.com Terms of Use, Privacy Policy, IPR and receive emails related to our services


Guangzhou King Yon Medical Tech Co., Ltd

8888 Trust Points

Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,,Changping,Guangdong,China

View Phone Number

sales@king-yon.com

Member Badge
1st Year

Surgical Gown 510K Level 3 Level 4 Certified

China

11901

( Negotiable ) Get Latest Price

China

-

50000 Piece

as per attach photo or brochure

As per cutomer requirements

300000 Piece per Day

T/T

surgical suit

Contact Now

Product Specification

AAMI PB70:2012 : EN 13795-1:2019 CE : TUV testing report for L2 L3 L4 Blue : Sterile EN ISO 15223-1:2016 : EN1041:2008 EN ISO 13485:2016 : EN ISO 14971:2012 EN 13795:2011 : TUV ISO 13485

Product Description

Product Name: Sterile Surgical Suit
Model No:According to Customer Specification
 
Certificate:
Surgical Gown
Test Report Based on EN 13795-1:2019
TUV Level 2 Test Report Based on AAMI PB70:2012
TUV Level 3 Test Report Based on AAMI PB70:2012
TUV Level 4 Test Report from TUV, Based on AAMI PB70:2012

TUV ISO 13485
 
We herewith declare that the above mentioned products meet the transposition into national law, the provisions of the following EC Council directives and Standards. All supporting documentations are retained under the premises of the manufacturer.
 
UMDNS Code:11901
Classification (MDD Annex IX): I Sterile, Rule 1
Conformity Assessment Route:Annex V section 3

General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC
Standard Applied:
 
EN ISO 15223-1:2016    EN1041:2008     EN ISO 13485:2016
EN ISO 14971:2012      EN 13795:2011
Notified Body:TV SD Products Service GmbH, Ridlestr. 65, 80339, Munchen, Germany
Identification Number:0123
(EC) Certificate(S):G2S 073966 0008 Rev.01
Expire Date of the Certificate:2024-05-26
Start of CE Marking:2010-11-26
Place,Date of Issue:Xuchang, 2019-10-15


*Ergonomic fit, enables freedom of movement
*Reinforced
*Breathable and comfortable, suitable for most procedures
*Specially treated to repel low-tension surface fluids
 
Manufacturing Center:10
Sterilization Center: 2
Employee: 4000
RD Center:2
Market: 74 Countries

image
  Surgical Gown 510K Level 3 Level 4 Certified Surgical Gown 510K Level 3 Level 4 Certified Surgical Gown 510K Level 3 Level 4 Certified

Contact Us

Contact Person :Mr. Sam

Company:Guangzhou King Yon Medical Tech Co., Ltd

Address:Room 302C, No.718, Blv San Yuan Li, Bai Yuan District,, Changping, Guangdong, China,510403

To,

Mr. Sam < Guangzhou King Yon Medical Tech Co., Ltd >
I want to know:

More Products From Guangzhou King Yon Medical Tech Co., Ltd

Surgical Suit with 510K And TUV CE Surgical Suit with 510K And
Sterile Surgical Suit TUV and 510K AAMI L4/3/2 EN13795 Sterile Surgical Suit TUV
510K L3/4 TUV CE Sterile Surgical suits 510K L3/4 TUV CE Sterile
CE Sterile Surgical Gowns CE Sterile Surgical Gowns
510K Level 3  Level 4 Sterile Surgical Suits 510K Level 3 Level 4
FFP2 NR Filtering Half Mask With CE (EN149) FFP2 NR Filtering Half Mask
FFP2 NR Filtering Half Mask With the CE (EN149) FFP2 NR Filtering Half Mask
KN95 Protective Disposable Facemask KN95 Protective Disposable
Medical Disposable Protective Coverall Medical Disposable
Surgical facemask Surgical facemask
Protective mask Protective mask
One-piece Disposable Protective Coverall Surgical Gown One-piece Disposable