The following data is part of a premarket notification filed by Royal Pacific Intl. Trade, Inc. with the FDA for Patient Examination Gloves.
| Device ID | K894192 |
| 510k Number | K894192 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ROYAL PACIFIC INTL. TRADE, INC. C/O GRAHAM & JAMES-ATTORNEYS 2000 M STREET, N.W., STE. 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli ROYAL PACIFIC INTL. TRADE, INC. C/O GRAHAM & JAMES-ATTORNEYS 2000 M STREET, N.W., STE. 700 Washington, DC 20036 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-08-01 |