The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powderfree Colored And Flavored Chloreprene Patient Examination Gloves Tested For Chemo Use.
| Device ID | K041913 |
| 510k Number | K041913 |
| Device Name: | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. MEDISAFE TECHNOLOGIES GG. TAMBAK REJO DESA BUNTU BEDIMBAR Tanjung Morawa, Medan, ID 20362 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT. MEDISAFE TECHNOLOGIES GG. TAMBAK REJO DESA BUNTU BEDIMBAR Tanjung Morawa, Medan, ID 20362 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-15 |
| Decision Date | 2004-12-01 |