The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn.bhd. with the FDA for Blue Latex Examination Powder Free Gloves.
Device ID | K192329 |
510k Number | K192329 |
Device Name: | Blue Latex Examination Powder Free Gloves |
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 Surbramaniam |
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 | 2019-08-27 |
Decision Date | 2019-11-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30796326000923 | K192329 | 000 |
30796326000954 | K192329 | 000 |
30796326000947 | K192329 | 000 |
30796326000930 | K192329 | 000 |