The following data is part of a premarket notification filed by Hebei Hongsen Plastics Technology Co, Ltd with the FDA for Powder Free Blue Nitrile Gloves, Tested For Use With Chemotherapy Drugs.
| Device ID | K163146 |
| 510k Number | K163146 |
| Device Name: | POWDER FREE Blue Nitrile GLOVES, Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD ESTERN INDUSTRIAL ZONE Nangong, CN 051800 |
| Contact | Shaozhang Nan |
| Correspondent | Ray Wang BEIJING BELIEVE TECH. SERVICE CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD.,LIYUAN, TONGZHOU DISTRICT Beijing, CN 101121 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043630791 | K163146 | 000 |
| 00850043630494 | K163146 | 000 |
| 00850043630999 | K163146 | 000 |
| 00850043630463 | K163146 | 000 |
| 00850043630500 | K163146 | 000 |