The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims..
| Device ID | K211022 |
| 510k Number | K211022 |
| Device Name: | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims. |
| Classification | Polymer Patient Examination Glove |
| Applicant | Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan, MY 36000 |
| Contact | Muhammad Abdul Rahman |
| Correspondent | Muhammad Abdul Rahman Central Medicare Sdn Bhd PT 2609-2620, Batu 8, Jalan Changkat Jong, Teluk Intan, MY 36000 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2021-12-22 |