The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Non Sterile Powder Free Polyurethane Examination Gloves (blue And Black Colors).
| Device ID | K203036 |
| 510k Number | K203036 |
| Device Name: | Non Sterile Powder Free Polyurethane Examination Gloves (Blue And Black Colors) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Contact | Fatin Nor Irdina Bt Ahmad Fauzi |
| Correspondent | Fatin Nor Irdina Bt Ahmad Fauzi Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-05 |
| Decision Date | 2021-05-07 |