The following data is part of a premarket notification filed by Hebei Manful Import & Export Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves, White (non-colored).
| Device ID | K051154 |
| 510k Number | K051154 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI MANFUL IMPORT & EXPORT CO., LTD. NO. 58 TONGDA ROAD Jinzhou City, Hebei, CN 052260 |
| Contact | Yanchai Zhang |
| Correspondent | Yanchai Zhang HEBEI MANFUL IMPORT & EXPORT CO., LTD. NO. 58 TONGDA ROAD Jinzhou City, Hebei, CN 052260 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2005-06-20 |
| Summary: | summary |