The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Glove (powderfree/hypoallergenic) (modification).
| Device ID | K954880 |
| 510k Number | K954880 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 26 LEEWARD ISLAND Clearwater, FL 34630 |
| Contact | Don Morris |
| Correspondent | Don Morris SIAM SEMPERMED CORP. LTD. 26 LEEWARD ISLAND Clearwater, FL 34630 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-17 |
| Decision Date | 1995-11-15 |