The following data is part of a premarket notification filed by Meditech Gloves Sdn Bhd with the FDA for Bpg Chemoplus Nitrile Patient Examination Gloves, Powder Free.
| Device ID | K213408 |
| 510k Number | K213408 |
| Device Name: | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Meditech Gloves SDN BHD PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, MY 71800 |
| Contact | Effendi Tenang |
| Correspondent | Wan Nadzifah Wan Hassan Meditech Gloves SDN BHD PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, MY 71800 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-10-19 |
| Decision Date | 2022-04-17 |