The following data is part of a premarket notification filed by Ningbo Yujiang Plastic & Rubber Co. Ltd. with the FDA for Nitrile Exam Glove, Powder Free.
| Device ID | K980677 |
| 510k Number | K980677 |
| Device Name: | NITRILE EXAM GLOVE, POWDER FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. 19001 S. RICHFIELD #185 Green Valley, AZ 85614 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-20 |
| Decision Date | 1998-03-16 |
| Summary: | summary |