The following data is part of a premarket notification filed by Eco Medi Glove Sdn. Bhd. with the FDA for Emg Pink Nitrile Examination Glove Powder Free.
| Device ID | K161320 |
| 510k Number | K161320 |
| Device Name: | EMG Pink Nitrile Examination Glove Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Taiping, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar ECO MEDI GLOVE SDN. BHD. LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA INDUSTRIAL ESTATE Kamunting Perak, MY 34600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-09-01 |
| Summary: | summary |