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 |