The following data is part of a premarket notification filed by Eco Medi Glove Sdn. Bhd with the FDA for Powder Free Nr Latex Surgical Glove (sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein.
| Device ID | K202401 |
| 510k Number | K202401 |
| Device Name: | Powder Free NR Latex Surgical Glove (Sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein |
| Classification | Surgeon's Gloves |
| Applicant | ECO Medi Glove Sdn. Bhd Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar ECO Medi Glove Sdn. Bhd Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping, MY 34600 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-02-17 |