The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Glove (powder Free).
| Device ID | K923862 |
| 510k Number | K923862 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE (POWDER FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 8-10 JOOTEE ANUSORN ROAD HATYAI, SONGKHLA Thailand, TH 90110 |
| Contact | Cherdkiatgumchai |
| Correspondent | Cherdkiatgumchai SIAM SEMPERMED CORP. LTD. 8-10 JOOTEE ANUSORN ROAD HATYAI, SONGKHLA Thailand, TH 90110 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-03 |
| Decision Date | 1993-02-10 |