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, Polymer Coating With Chemotherapy Claim.
| Device ID | K080520 |
| 510k Number | K080520 |
| Device Name: | NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM |
| 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 | 2008-02-25 |
| Decision Date | 2008-04-30 |
| Summary: | summary |