The following data is part of a premarket notification filed by Haining Medical Products Co., Ltd. with the FDA for Nitrile Glove Powder Free Black.
| Device ID | K182528 |
| 510k Number | K182528 |
| Device Name: | Nitrile Glove Powder Free Black |
| Classification | Polymer Patient Examination Glove |
| Applicant | Haining Medical Products Co., Ltd. West Of Dianchang Road, Luannan County Tangshan, CN 063500 |
| Contact | Zhiming Yao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 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 | 2018-09-14 |
| Decision Date | 2018-11-15 |
| Summary: | summary |