The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (blue).
| Device ID | K200581 |
| 510k Number | K200581 |
| Device Name: | Biodegradable Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) |
| 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 | 2020-03-05 |
| Decision Date | 2020-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864060271 | K200581 | 000 |
| 20686864060264 | K200581 | 000 |
| 20686864060257 | K200581 | 000 |
| 20686864060240 | K200581 | 000 |
| 20686864060233 | K200581 | 000 |
| 00686864060741 | K200581 | 000 |