The following data is part of a premarket notification filed by Dipped Products (thailand) Ltd with the FDA for Palm Pro Premium, Model 6pf1 & Palm Pro, Model 6pf2, Latex Exam Glove.
| Device ID | K050152 |
| 510k Number | K050152 |
| Device Name: | PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | DIPPED PRODUCTS (THAILAND) LTD 2454 MCMULLEN BOOTH ROAD SUITE 427 Clearwater, FL 33759 |
| Contact | Ian P Gordon |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-02-07 |
| Summary: | summary |