The following data is part of a premarket notification filed by Tangshan Zhongpu Plastic Products Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (yellow).
| Device ID | K100058 |
| 510k Number | K100058 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD ROOM 1606 BLDG 1, JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO 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 | 2010-01-08 |
| Decision Date | 2010-03-05 |
| Summary: | summary |