The following data is part of a premarket notification filed by Medi Legion Sdn.bhd with the FDA for Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves.
| Device ID | K212349 |
| 510k Number | K212349 |
| Device Name: | Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Medi Legion Sdn.Bhd No.6D, Plot 4, Pt 427, Jalan Waja 14, Teluk Panglima Garang Kuala Langat, MY 42500 |
| Contact | N.s. Kumar |
| Correspondent | N.s. Kumar Medi Legion Sdn.Bhd No.6D, Plot 4, Pt 427, Jalan Waja 14, Teluk Panglima Garang Kuala Langat, MY 42500 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-28 |
| Decision Date | 2021-12-10 |