The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Nitrile Patient Examination Glove (green Color) Powdered, Non Sterile.
| Device ID | K002819 |
| 510k Number | K002819 |
| Device Name: | NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684 |
| Contact | William Harris |
| Correspondent | William Harris SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-11-29 |