The following data is part of a premarket notification filed by Dipped Products (thailand) Ltd with the FDA for Palm-pro Powder Free Nitrile Examination Gloves.
| Device ID | K111464 |
| 510k Number | K111464 |
| Device Name: | PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | DIPPED PRODUCTS (THAILAND) LTD 82/2 MOO 9, TUMBON RATTAPUM AMPHUR KHUN NIENG Songkla, TH 90220 |
| Contact | L.g.s. Gunawardana |
| Correspondent | L.g.s. Gunawardana DIPPED PRODUCTS (THAILAND) LTD 82/2 MOO 9, TUMBON RATTAPUM AMPHUR KHUN NIENG Songkla, TH 90220 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-26 |
| Decision Date | 2012-04-19 |
| Summary: | summary |