The following data is part of a premarket notification filed by Fitone Latex Products Co., Ltd. Guangdong with the FDA for Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K221747 |
| 510k Number | K221747 |
| Device Name: | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong Road, Lingbei Industrial Zone, Suixi Zhanjiang, CN 524338 |
| Contact | Christine Ou |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai, CN 200072 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-16 |
| Decision Date | 2022-12-01 |