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 K213681
Device Name Ivory Glove Powder-Free Nitrile Examination Gloves
Applicant
Ivory Gloves Sdn. Bhd.
Lot 7806 Jalan Perusahaan 1, Kawasan Perindustrian
Kamunting,  MY 34600
Applicant Contact Arasi No Last Name Provided
Correspondent
Novo Quality Services Sdn Bhd
Unit No 625 & 627, Block A, Kelana Centre Point 3
Jalan Ss7/19, Kelana Jaya
Petaling Jaya,  MY 47301
Correspondent Contact Lim Pooi Yee
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/22/2021
Decision Date 04/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-