The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn. Bhd. with the FDA for Jr Medic Blue Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K221626 |
| 510k Number | K221626 |
| Device Name: | Jr Medic Blue Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | JR Engineering & Medical Technologies (M) SDN. BHD. Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, Pusat Perindustrian 2 Hulu Selangor, MY 44200 |
| Contact | Ganesan Subramaniam |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, IL 60504 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-12-07 |