The following data is part of a premarket notification filed by P.a. Research Corp. with the FDA for Patient Examination Gloves (poly).
| Device ID | K892771 |
| 510k Number | K892771 |
| Device Name: | PATIENT EXAMINATION GLOVES (POLY) |
| Classification | Polymer Patient Examination Glove |
| Applicant | P.A. RESEARCH CORP. 555 E. LINDEN AVE. Linden, NJ 07036 |
| Contact | Schoenfelder |
| Correspondent | Schoenfelder P.A. RESEARCH CORP. 555 E. LINDEN AVE. Linden, NJ 07036 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-09-13 |