The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination (powderfree Glove).
| Device ID | K970794 |
| 510k Number | K970794 |
| Device Name: | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 110 MOO, 8 KANJANAWANID RD., THAMBON PATONG Hatyai, Songkhla, TH 90230 |
| Contact | Poonsuk Cherdkiatgumchai |
| Correspondent | Poonsuk Cherdkiatgumchai SIAM SEMPERMED CORP. LTD. 110 MOO, 8 KANJANAWANID RD., THAMBON PATONG Hatyai, Songkhla, TH 90230 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-05-06 |
| Summary: | summary |