The following data is part of a premarket notification filed by Zhangjiagang Fengyuan Plastic Products Co., Ltd. with the FDA for Nitrile Patient Examination Gloves.
| Device ID | K211351 |
| 510k Number | K211351 |
| Device Name: | Nitrile Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | ZHANGJIAGANG FENGYUAN PLASTIC PRODUCTS CO., LTD. No.333,Fumin Middle Road,Tangqiao Town, Shangqiu, CN 215615 |
| Contact | Huamei Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng 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 | 2021-05-03 |
| Decision Date | 2021-08-13 |