The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Non-sterile, Powdered Latex Examination Glove.
| Device ID | K081910 |
| 510k Number | K081910 |
| Device Name: | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
| Contact | John Calhoun |
| Correspondent | John Calhoun 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 | 2008-07-03 |
| Decision Date | 2008-09-17 |
| Summary: | summary |