The following data is part of a premarket notification filed by Siam Sempermed Corp., Ltd with the FDA for Nitrile Examination Gloves With Aloe & Vitamin E, Powder- Free.
| Device ID | K142685 |
| 510k Number | K142685 |
| Device Name: | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SIAM SEMPERMED CORP., LTD 10 SOI 10 PHETKASEM RD. Hatyai, TH 90110 |
| Contact | Anan Pruksanusak |
| Correspondent | John Calhoun SEMPERMED USA, INC. 13900 49TH STREET NORTH Clearwater, FL 33762 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-02-11 |
| Summary: | summary |