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 Surgeon'S Gloves
510(k) Number K230578
Device Name Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Applicant
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi
Sepang,  MY 43900
Applicant Contact Saravanan Ramasamy
Correspondent
Wrp USA, Inc.
3700 Massillon Rd.
Suite 340
Uniontown,  OH  44685
Correspondent Contact Michael Scaglione
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received03/01/2023
Decision Date 08/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-