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 Latex Patient Examination Glove
510(k) Number K101799
Device Name POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
Applicant
Wear Safe (Malaysia) Sdn. Bhd.
Lot Pt. 13726,Jalan Haji Salleh
Off Jalan Meru
Klang, Selangor Darul Ehsan,  MY 41050
Applicant Contact MOHD AZLAN
Correspondent
Wear Safe (Malaysia) Sdn. Bhd.
Lot Pt. 13726,Jalan Haji Salleh
Off Jalan Meru
Klang, Selangor Darul Ehsan,  MY 41050
Correspondent Contact MOHD AZLAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/28/2010
Decision Date 09/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-