The following data is part of a premarket notification filed by Eco Medi Glove Sdn. Bhd with the FDA for Emg Blue Nitrile Medical Examination Glove Powder Free.
| Device ID | K141590 |
| 510k Number | K141590 |
| Device Name: | EMG BLUE NITRILE MEDICAL 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, Perak, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar ECO MEDI GLOVE SDN. BHD LOT 23826, JALAN TEMBAGA KUNING, KAMUNTING RAYA, INDUSTRIAL ESTATE Taiping, 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 | 2014-06-13 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30850015524043 | K141590 | 000 |
| 19551012410014 | K141590 | 000 |
| 19551012410021 | K141590 | 000 |
| 19551012410038 | K141590 | 000 |
| 19551012410045 | K141590 | 000 |
| 19551012412810 | K141590 | 000 |
| 19551012412827 | K141590 | 000 |
| 19551012412834 | K141590 | 000 |
| 19551012412841 | K141590 | 000 |
| 19551012412858 | K141590 | 000 |
| 19551012412865 | K141590 | 000 |
| 10850015524001 | K141590 | 000 |
| 10850015524018 | K141590 | 000 |
| 10850015524025 | K141590 | 000 |
| 10850015524032 | K141590 | 000 |
| 10850015524049 | K141590 | 000 |
| 10850015524414 | K141590 | 000 |
| 19551012410007 | K141590 | 000 |