The following data is part of a premarket notification filed by Edma Group, Llc with the FDA for Edma Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K211547 |
| 510k Number | K211547 |
| Device Name: | Edma Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Edma Group, LLC 3634 E Piccadilly Rd Phoenix, AZ 85018 |
| Contact | Vio Cretu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-19 |
| Decision Date | 2021-07-15 |