The following data is part of a premarket notification filed by Shijiazhuang Manful Light Industrial Products Co., with the FDA for Powder-free Vinyl Patient Examination Gloves Colored (white, Yellow).
| Device ID | K051156 |
| 510k Number | K051156 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 1606, BLDG 1 JIANXIANG YUAN NO 209 BIE SI HUAN ZHONG ROAD Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 1606, BLDG 1 JIANXIANG YUAN NO 209 BIE SI HUAN ZHONG ROAD 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 | 2005-05-04 |
| Decision Date | 2005-06-14 |
| Summary: | summary |