FDA 510K & TUV Surgical Suit Based on AAMI PB70:2012 of Guangzhou King Yon Medical Tech Co ., Ltd


Description of the Product

(More detals pls download the PDF)
Surgical Gown FDA 510K Registration Record
Test Report Based on EN 13795-1:2019
Level 2 Test Report Based on AAMI PB70:2012
Level 3 Test Report Based on AAMI PB70:2012
Level 4 Test Report from TUV, Based on AAMI PB70:2012

UMDNS Code:11901
Classification (MDD Annex IX): I Sterile, Rule 1
Conformity Assessment Route:Annex V section 3 

*Ergonomic fit, enables freedom of movement
*Breathable and comfortable, suitable for most procedures
*Specially treated to repel low-tension surface fluids
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.
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:TUV SUD 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

Price and payment

Price not indicated
  • Bank transfer

Characteristics of the Product

  • Type Surgical Suit with FDA 510K & TUV Based on AAMI PB70:2012
  • Model According to Customer Specification
  • Brand ZD
  • Certification TUV, FDA with 510K, based on AAMI PB70:2012
  • Origin China