The following data is part of a premarket notification filed by Clinical Supply with the FDA for Posi Shield (patient Examination Gloves).
| Device ID | K892475 |
| 510k Number | K892475 |
| Device Name: | POSI SHIELD (PATIENT EXAMINATION GLOVES) |
| Classification | Latex Patient Examination Glove |
| Applicant | CLINICAL SUPPLY 7969 CINCINNATI DAYTON RD. West Chester, OH 45069 |
| Contact | Mark Carnahan |
| Correspondent | Mark Carnahan CLINICAL SUPPLY 7969 CINCINNATI DAYTON RD. West Chester, OH 45069 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-07 |
| Decision Date | 1989-05-08 |