The following data is part of a premarket notification filed by Suqian Ruijang Medical Supplies Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, White Color.
| Device ID | K113194 |
| 510k Number | K113194 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD HAI DI Chu Xiaoan, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD 1 JIAN XIANG YUAN NO. 209 BEI SI HUAN ZHONG RD HAI DI Chu Xiaoan, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-05-14 |
| Summary: | summary |