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 K915251
Device Name PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC
Applicant
Supermax Sdn Bhd
27a Jalan Ss 19/6c,Subang Jaya
47500 Petaling Jaya
Selangor, Malaysia,  MG
Applicant Contact STANLEY THAI
Correspondent
Supermax Sdn Bhd
27a Jalan Ss 19/6c,Subang Jaya
47500 Petaling Jaya
Selangor, Malaysia,  MG
Correspondent Contact STANLEY THAI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/13/1991
Decision Date 01/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-