The following data is part of a premarket notification filed by Lic-orthion with the FDA for Patient Examination Gloves (latex).
| Device ID | K891649 |
| 510k Number | K891649 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | LIC-ORTHION P.O. BOX 1040 1117 JEFFERSON STREET Lynchburg, VA 24505 |
| Contact | Boyd, Ph |
| Correspondent | Boyd, Ph LIC-ORTHION P.O. BOX 1040 1117 JEFFERSON STREET Lynchburg, VA 24505 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-04-04 |