The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Non-sterile, Powder-free Latex Examination Gloves With Polymer Coating, Aloe, Vitamin E And Protein Claim.
| Device ID | K024121 |
| 510k Number | K024121 |
| Device Name: | NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684 |
| Contact | William E Harris |
| Correspondent | Neil E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2002-12-20 |
| Summary: | summary |