The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn.bhd. with the FDA for Jr Medic Nitrile Examination Gloves Powder Free (orange, Purple).
| Device ID | K222349 |
| 510k Number | K222349 |
| Device Name: | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) |
| 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. STE114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-10-21 |