The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (blue) - Extended Cuff.
| Device ID | K190454 |
| 510k Number | K190454 |
| Device Name: | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue) - Extended Cuff |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega Ngc Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Hartalega Sdn. Bhd No.7, Kawasan Perusahaan Suria Bestari Jaya, MY 45600 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059530 | K190454 | 000 |
| 20686864029155 | K190454 | 000 |
| 20686864029148 | K190454 | 000 |
| 20686864029131 | K190454 | 000 |
| 20686864029124 | K190454 | 000 |
| 20686864029117 | K190454 | 000 |