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, Lavender Blue Color, Polymer Coated, Texted With Chemotherapy Drugs.
| Device ID | K083755 |
| 510k Number | K083755 |
| Device Name: | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED 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 | 2008-12-17 |
| Decision Date | 2009-03-05 |
| Summary: | summary |