The following data is part of a premarket notification filed by Zibo Lanhua Medical Packaging Material Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves (blue, White And Black), Tested For Use With Chemotherapy Drugs And Fentanyl.
| Device ID | K222815 |
| 510k Number | K222815 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue, White And Black), Tested For Use With Chemotherapy Drugs And Fentanyl |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zibo Lanhua Medical Packaging Material Co., Ltd No. 21 Qingtian Road, Xindian Street, Zibo, CN 255414 |
| Contact | Lily Wang |
| Correspondent | Lily Wang Zibo Lanhua Medical Packaging Material Co., Ltd No. 21 Qingtian Road, Xindian Street, Zibo, CN 255414 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-19 |
| Decision Date | 2022-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847713000510 | K222815 | 000 |
| 00847713000558 | K222815 | 000 |
| 00847713000435 | K222815 | 000 |
| 00847713000411 | K222815 | 000 |
| 20850020922608 | K222815 | 000 |
| 20850020922592 | K222815 | 000 |
| 20850020922585 | K222815 | 000 |
| 20850020922578 | K222815 | 000 |
| 20850020922561 | K222815 | 000 |