The following data is part of a premarket notification filed by Dipped Products Limited with the FDA for Palm-pro 0.30mm Powder Free Latex Examinaion Gloves (6pf2g30).
| Device ID | K100895 |
| 510k Number | K100895 |
| Device Name: | PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) |
| Classification | Latex Patient Examination Glove |
| Applicant | DIPPED PRODUCTS LIMITED 400 DEANS ROAD Columbo, LK 10 |
| Contact | W.s.e.f. Fernando |
| 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 | 2010-03-31 |
| Decision Date | 2011-05-27 |
| Summary: | summary |