The following data is part of a premarket notification filed by Eco Medi Glove Sdn Bhd with the FDA for Gen 2 Nitrile Examination Glove (blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims.
| Device ID | K193121 |
| 510k Number | K193121 |
| Device Name: | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims |
| Classification | Polymer Patient Examination Glove |
| Applicant | ECO Medi Glove SDN BHD Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, Perak, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar ECO Medi Glove SDN BHD Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 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 | 2019-11-12 |
| Decision Date | 2020-03-20 |