The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Glove Powderfree (blue Color) Polymer Coated.
| Device ID | K981975 |
| 510k Number | K981975 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684 |
| Contact | Don Morris |
| Correspondent | Don Morris SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-05 |
| Decision Date | 1998-11-20 |
| Summary: | summary |