The following data is part of a premarket notification filed by Jr Engineering & Medical Technologies (m) Sdn.bhd. with the FDA for Blue Nitrile Examination Gloves Powder Free.
| Device ID | K192333 |
| 510k Number | K192333 |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| 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 Sburamaniam |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr, STE 114 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 | 2019-08-27 |
| Decision Date | 2020-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850020592500 | K192333 | 000 |
| 00850020592494 | K192333 | 000 |
| 00850020592487 | K192333 | 000 |
| 00850020592470 | K192333 | 000 |