The following data is part of a premarket notification filed by Tangshan Zhonghong Pulin Plastic Co.,ltd with the FDA for Power-free Vinyl Patient Examination Gloves, Clear(non-colored).
| Device ID | K120968 |
| 510k Number | K120968 |
| Device Name: | POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD RM 1606 BLDG 1 JIANXIANG YUAN NO.209 BEI SHI HUAN ZHO Beijing, CN Ch |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD RM 1606 BLDG 1 JIANXIANG YUAN NO.209 BEI SHI HUAN ZHO Beijing, CN Ch |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-30 |
| Decision Date | 2012-09-19 |
| Summary: | summary |