The following data is part of a premarket notification filed by Shijiazhuang Wally Plastics Co., Ltd with the FDA for Powder Free Yellow Synthetic Vinyl Patient Examination Gloves.
| Device ID | K131344 |
| 510k Number | K131344 |
| Device Name: | POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG WALLY PLASTICS CO., LTD RM.1606, BLD.1 JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. HAIDIAN DISTRICT Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SHIJIAZHUANG WALLY PLASTICS CO., LTD RM.1606, BLD.1 JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. HAIDIAN DISTRICT Beijing, 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 | 2013-05-09 |
| Decision Date | 2014-01-30 |
| Summary: | summary |