The following data is part of a premarket notification filed by Siem Aempemed Corp., Ltd with the FDA for Non-sterile, Powder-free Nitrile Examination Glove, Blue, Tested For Use With Chemotherapy Drugs.
Device ID | K111134 |
510k Number | K111134 |
Device Name: | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
Classification | Polymer Patient Examination Glove |
Applicant | SIEM AEMPEMED CORP., LTD 13900 49TH STREET Clearwater, FL 33762 |
Contact | William E Harris, Iii |
Correspondent | William E Harris, Iii SIEM AEMPEMED CORP., LTD 13900 49TH STREET 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 | 2011-04-22 |
Decision Date | 2012-01-26 |
Summary: | summary |