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, Non-sterile.
| Device ID | K891365 |
| 510k Number | K891365 |
| Device Name: | LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O SCITECH MEDICAL PRODUCTS P.O. BOX 796 New Hyde Park, NY 11040 |
| Contact | Kenneth Gross |
| Correspondent | Kenneth Gross CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O SCITECH MEDICAL PRODUCTS P.O. BOX 796 New Hyde Park, NY 11040 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-04-26 |