The following data is part of a premarket notification filed by Yongxin Healthcare Co., Ltd. with the FDA for Yongxin Nitrile Powder Free Patient Examination Gloves, Blue Color.
| Device ID | K141304 |
| 510k Number | K141304 |
| Device Name: | YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | YONGXIN HEALTHCARE 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 YONGXIN HEALTHCARE 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 | 2014-05-19 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10699320402259 | K141304 | 000 |
| 00724351996859 | K141304 | 000 |
| 00724351996842 | K141304 | 000 |
| 00724351996835 | K141304 | 000 |
| 00724351256502 | K141304 | 000 |
| 00724351259473 | K141304 | 000 |
| 00724351259466 | K141304 | 000 |
| 00724351256472 | K141304 | 000 |
| 00724351225751 | K141304 | 000 |
| 00724351996866 | K141304 | 000 |
| 00699320000670 | K141304 | 000 |
| 10699320402617 | K141304 | 000 |
| 10699320402242 | K141304 | 000 |
| 10699320402235 | K141304 | 000 |
| 10699320402228 | K141304 | 000 |
| 10699320402211 | K141304 | 000 |
| 10699320402655 | K141304 | 000 |
| 10699320402648 | K141304 | 000 |
| 10699320402631 | K141304 | 000 |
| 10699320402624 | K141304 | 000 |
| 00724351225737 | K141304 | 000 |