The following data is part of a premarket notification filed by Huikang Glove Co., Ltd. with the FDA for Huikang Nitrile Powder Free Patient Exam Gloves, Blue Color.
| Device ID | K141287 |
| 510k Number | K141287 |
| Device Name: | HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | HUIKANG GLOVE CO., LTD. ROOM 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan HUIKANG GLOVE 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 | 2014-05-16 |
| Decision Date | 2014-12-03 |
| Summary: | summary |