The following data is part of a premarket notification filed by Ningbo Yujiang Plastic & Rubber Co. Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K894386 |
| 510k Number | K894386 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. ECONOMIC & TECH. DEVELOPMENT, ZONE G-4 Ningbo, Zhejiang Prov., CN 315803 |
| Contact | Song Hai-ping |
| Correspondent | Song Hai-ping NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. ECONOMIC & TECH. DEVELOPMENT, ZONE G-4 Ningbo, Zhejiang Prov., CN 315803 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-21 |