The following data is part of a premarket notification filed by Zhonghong Pulin Medical Products Co., Ltd. with the FDA for Nitrile Powder Free Patient Examination Gloves, Blue Color.
| Device ID | K152712 |
| 510k Number | K152712 |
| Device Name: | Nitrile Powder Free Patient Examination Gloves, Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zhonghong Pulin Medical Products Co., Ltd. Pachigang Industrial Park, Luannan County Tangshan, CN 063502 |
| Contact | Li Jinge |
| Correspondent | Chu Xiaoan CHU XIAOAN Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan ZhongRd Haidian Dis Beijing, CN 100083 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-03-09 |
| Summary: | summary |