The following data is part of a premarket notification filed by China National Medicines & Health Prod. I/e Corp. with the FDA for Latex Examination Gloves (mfg. Anhui Bengbu Latex).
| Device ID | K893351 |
| 510k Number | K893351 |
| Device Name: | LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. 196 JINGWU ROAD, HANKOU Wuhan Hubei, CN |
| Contact | Wei-min Hu |
| Correspondent | Wei-min Hu CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. 196 JINGWU ROAD, HANKOU Wuhan Hubei, CN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-21 |
| Decision Date | 1989-11-17 |