The following data is part of a premarket notification filed by Zibo Shengkun Chemical Industrial Co., Ltd with the FDA for Shengkun Chemical.
| Device ID | K110621 |
| 510k Number | K110621 |
| Device Name: | SHENGKUN CHEMICAL |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD FINE CHEMICAL PARK, CHEMICAL INDUSTRY PARK ZIBO, SHANDONG Zibo, Shandong, CN 255400 |
| Contact | Jason Liu |
| Correspondent | Jason Liu ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD FINE CHEMICAL PARK, CHEMICAL INDUSTRY PARK ZIBO, SHANDONG Zibo, Shandong, CN 255400 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-08-24 |
| Summary: | summary |