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 Vinyl Patient Examination Glove
510(k) Number K010830
Device Name POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
Applicant
General Gloves Corp.
25 Pei Ma, 16 Lin Tung Chung
Village, Tung Shan Hsiang
Tainan Hsien,  TW 733
Applicant Contact JOHN CHEN
Correspondent
General Gloves Corp.
25 Pei Ma, 16 Lin Tung Chung
Village, Tung Shan Hsiang
Tainan Hsien,  TW 733
Correspondent Contact JOHN CHEN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/20/2001
Decision Date 04/09/2001
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
-
-