The following data is part of a premarket notification filed by Siyang Jaysun Medtech Co., Ltd. with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Color.
| Device ID | K211864 |
| 510k Number | K211864 |
| Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Siyang Jaysun Medtech Co., Ltd. No.26 Changjiang Rd, Siyang Economic Development Zone Suqian, CN 223700 |
| Contact | Chen Fang |
| Correspondent | Chu Xiaoan Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang,Chaoyang District Beijing, CN 100121 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2022-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974930241021 | K211864 | 000 |