The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (black).
| Device ID | K200019 |
| 510k Number | K200019 |
| Device Name: | Nitrile Powder Free Examination Gloved Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Black) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega NGC Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega NGC Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| 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 | 2020-01-03 |
| Decision Date | 2020-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059462 | K200019 | 000 |
| 20686864040839 | K200019 | 000 |
| 20686864040716 | K200019 | 000 |
| 20686864040709 | K200019 | 000 |
| 20686864040693 | K200019 | 000 |
| 20686864040686 | K200019 | 000 |