The following data is part of a premarket notification filed by Zhenjiang Suhui Latex Products Co., Ltd. with the FDA for Nitrile Examination Gloves, Green/ Blue/ Black Color.
| Device ID | K211778 |
| 510k Number | K211778 |
| Device Name: | Nitrile Examination Gloves, Green/ Blue/ Black Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zhenjiang SuHui Latex Products Co., Ltd. Lianhe Village, Xinba Town Yangzhong, CN 212212 |
| Contact | Zhengfu Sun |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.1601, East Lujiazui Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2021-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974466380140 | K211778 | 000 |
| 06974466380027 | K211778 | 000 |
| 06974466380058 | K211778 | 000 |
| 06974466380003 | K211778 | 000 |
| 06974466380034 | K211778 | 000 |
| 06974466380041 | K211778 | 000 |
| 06974466380065 | K211778 | 000 |
| 06974466380072 | K211778 | 000 |
| 06974466380089 | K211778 | 000 |
| 06974466380096 | K211778 | 000 |
| 06974466380102 | K211778 | 000 |
| 06974466380119 | K211778 | 000 |
| 06974466380126 | K211778 | 000 |
| 06974466380133 | K211778 | 000 |
| 06974466380010 | K211778 | 000 |