The following data is part of a premarket notification filed by Dong Tai City Huayi Gloves Co.,ltd. with the FDA for Nitrile Examination Gloves.
| Device ID | K213843 |
| 510k Number | K213843 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Dong Tai City Huayi Gloves Co.,Ltd. No.36 Nanzhuang Road, Dongtai High-Tech Industrial Development Zone Dongtai, CN 224249 |
| Contact | Huamei Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East 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 | 2021-12-09 |
| Decision Date | 2022-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03630148904938 | K213843 | 000 |
| 00630148663838 | K213843 | 000 |
| 00630148663821 | K213843 | 000 |
| 00630148663814 | K213843 | 000 |