The following data is part of a premarket notification filed by Derma Care Plus Products, Llc with the FDA for Powder Free Nitrile Patient Examination Glove With Colloidal Oatmeal Usp A Skin Protectant Drug.
| Device ID | K111589 |
| 510k Number | K111589 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG |
| Classification | Polymer Patient Examination Glove |
| Applicant | DERMA CARE PLUS PRODUCTS, LLC 2614 MAIN STREET Green Bay, WI 54311 |
| Contact | Joseph Neuser |
| Correspondent | Joseph Neuser DERMA CARE PLUS PRODUCTS, LLC 2614 MAIN STREET Green Bay, WI 54311 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-07 |
| Decision Date | 2011-08-23 |