The following data is part of a premarket notification filed by Haining Medical Products Co., Ltd with the FDA for Haining Nitrile Powder Free Patient Examination Gloves, Blue Color.
| Device ID | K152715 |
| 510k Number | K152715 |
| Device Name: | HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | HAINING MEDICAL PRODUCTS CO., LTD WEST OF DIANCHANG ROAD LUANNAN COUNTY Tangshan, CN 063500 |
| Contact | Zhang Liang |
| Correspondent | Chu Xiaoan HAINING MEDICAL PRODUCTS CO., LTD. ROOM 1606 BLDG. 1 .JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG ROAD, 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 | 2016-02-25 |
| Summary: | summary |