The following data is part of a premarket notification filed by Yuanhang Plastic Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves, Clear(non-colored).
| Device ID | K122835 |
| 510k Number | K122835 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | YUANHANG PLASTIC CO., LTD RM. 1606 BLDG 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan YUANHANG PLASTIC CO., LTD RM. 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 | 2012-09-17 |
| Decision Date | 2012-12-10 |