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 Polymer Patient Examination Glove
510(k) Number K010863
Device Name LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
Applicant
La Glove (M) Sdn. Bhd.
Lot 478 Jalan Simpang Balak,
Off Batu 13, Jalan Cheras
Kajang Selangpr D.E.,  MY 43000
Applicant Contact G. BASKARAN
Correspondent
La Glove (M) Sdn. Bhd.
Lot 478 Jalan Simpang Balak,
Off Batu 13, Jalan Cheras
Kajang Selangpr D.E.,  MY 43000
Correspondent Contact G. BASKARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/22/2001
Decision Date 05/03/2001
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
-
-