The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Sterile Powder-free Latex Examination Gloves With Polymer Coating And Protein Claim (50 Ug Or Less).
| Device ID | K051329 |
| 510k Number | K051329 |
| Device Name: | STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS) |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-07-19 |
| Summary: | summary |