The following data is part of a premarket notification filed by Zhida Glove Co., Ltd. with the FDA for Zhida Nitrile Powder Free Patient Examination Gloves, Blue Color.
| Device ID | K141303 |
| 510k Number | K141303 |
| Device Name: | ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | ZHIDA 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 ZHIDA 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 | 2014-05-19 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00369771001495 | K141303 | 000 |
| 00810998039322 | K141303 | 000 |
| 00810998039308 | K141303 | 000 |
| 00810998039285 | K141303 | 000 |
| 00810998039551 | K141303 | 000 |
| 00810998039537 | K141303 | 000 |
| 00810998039513 | K141303 | 000 |
| 00810998039490 | K141303 | 000 |
| 00810998035577 | K141303 | 000 |
| 00810998034761 | K141303 | 000 |
| 00810998034747 | K141303 | 000 |
| D883AA00703 | K141303 | 000 |
| D883AA00713 | K141303 | 000 |
| D883AA00723 | K141303 | 000 |
| 00369771001471 | K141303 | 000 |
| 00369771001457 | K141303 | 000 |
| 00369771001433 | K141303 | 000 |
| D883AA00843 | K141303 | 000 |
| D883AA00833 | K141303 | 000 |
| D883AA00823 | K141303 | 000 |
| D883AA00813 | K141303 | 000 |
| D883AA00803 | K141303 | 000 |
| D883AA00743 | K141303 | 000 |
| D883AA00733 | K141303 | 000 |
| 00810998034723 | K141303 | 000 |