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 With Polymer Coating.
| Device ID | K070639 |
| 510k Number | K070639 |
| Device Name: | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING |
| 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 | 2007-03-07 |
| Decision Date | 2007-06-15 |
| Summary: | summary |