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 |