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 Examintion Gloves.
| Device ID | K042119 |
| 510k Number | K042119 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINTION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 707, AVIC BLDG, NO 2 DONG SAN HUAN NAN ROAD Chaoyang; Beijing, CN 10002 |
| Contact | Chen Yuhong |
| Correspondent | Chen Yuhong SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., RM 707, AVIC BLDG, NO 2 DONG SAN HUAN NAN ROAD Chaoyang; Beijing, CN 10002 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-06 |
| Decision Date | 2004-11-03 |