The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn.bhd. with the FDA for Jr Medic.
| Device ID | K222348 |
| 510k Number | K222348 |
| Device Name: | JR MEDIC |
| Classification | Latex 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 | LYY |
| 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 | 2022-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017044913 | K222348 | 000 |
| 00850017044838 | K222348 | 000 |
| 00850017044845 | K222348 | 000 |
| 00850017044852 | K222348 | 000 |
| 00850017044869 | K222348 | 000 |
| 00850017044876 | K222348 | 000 |
| 00850017044883 | K222348 | 000 |
| 00850017044890 | K222348 | 000 |
| 00850017044906 | K222348 | 000 |
| 00850017044821 | K222348 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() JR MEDIC 97070810 not registered Live/Pending |
Zinntex LLC 2021-10-12 |