The following data is part of a premarket notification filed by Derma Care Plus Products Llc with the FDA for Powder Free Chlorinated Latex Patient Examination Glove.
| Device ID | K070760 |
| 510k Number | K070760 |
| Device Name: | POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | DERMA CARE PLUS PRODUCTS LLC 1500 RIVER PINES DRIVE Green Bay, WI 54311 |
| Contact | Joseph Neuser |
| Correspondent | Joseph Neuser DERMA CARE PLUS PRODUCTS LLC 1500 RIVER PINES DRIVE Green Bay, WI 54311 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-06-07 |