The following data is part of a premarket notification filed by China National Medicines & Health Prod. I/e Corp. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892916 |
| 510k Number | K892916 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O CORPCO INTL., SUITE 916 PENN. BLDG. 225 W. 34TH ST. New York, NY 10001 |
| Contact | Eddie K Soo |
| Correspondent | Eddie K Soo CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O CORPCO INTL., SUITE 916 PENN. BLDG. 225 W. 34TH ST. New York, NY 10001 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-12 |
| Decision Date | 1989-07-14 |