The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Non-sterile, Powder Free Nitrile Examination Glove, Blue Color, Polymer Coated, Tested With Chemotherapy Drugs.
Device ID | K082957 |
510k Number | K082957 |
Device Name: | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS |
Classification | Polymer Patient Examination Glove |
Applicant | SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
Contact | William E Harris |
Correspondent | William E Harris SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-03 |
Decision Date | 2009-05-29 |
Summary: | summary |