Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Gown, Surgical
510(k) Number K252301
Device Name Henan Yadu Level 4 Surgical Gowns (Reinforced)
Applicant
Yadu Medical (Henan) Co., Ltd.
66 Yangze Rd., Nanpu District, Changyuan, Xinxiang,
He Nan,  CN 453400
Applicant Contact Peilong Shi
Correspondent
Yadu Medical (Henan) Co., Ltd.
66 Yangze Rd., Nanpu District, Changyuan, Xinxiang,
He Nan,  CN 453400
Correspondent Contact Peilong Shi
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/24/2025
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
-
-