The following data is part of a premarket notification filed by Guangdong Kingfa Sci. & Tech. Co., Ltd. with the FDA for Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs.
| Device ID | K211220 |
| 510k Number | K211220 |
| Device Name: | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guangdong Kingfa Sci. & Tech. Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Contact | Xiaoge Yu |
| Correspondent | Xiaoge Yu Guangdong Kingfa Sci. & Tech. Co., Ltd. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| 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 | 2021-04-23 |
| Decision Date | 2021-07-22 |