The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Glove.
| Device ID | K940022 |
| 510k Number | K940022 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. RD.THAMBON PATONG HATYAI, SONGKHLA Thailand, TH 90230 |
| Contact | Poonsuk Cherdkiatgumchai |
| Correspondent | Poonsuk Cherdkiatgumchai SIAM SEMPERMED CORP. LTD. RD.THAMBON PATONG HATYAI, SONGKHLA Thailand, 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 | 1994-01-03 |
| Decision Date | 1994-05-26 |