The following data is part of a premarket notification filed by Ningbo Yujiang Plastic & Rubber Co. Ltd. with the FDA for Ningbo Yujiang Latex Examination Gloves, Powder-free, With Protein Labeling.
| Device ID | K964847 |
| 510k Number | K964847 |
| Device Name: | NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING |
| Classification | Latex Patient Examination Glove |
| Applicant | NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Contact | Janna Tucker |
| Correspondent | Janna Tucker NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-02-27 |