The following data is part of a premarket notification filed by Brandywine Surgical, Inc. with the FDA for Spring Latex Examination Gloves.
| Device ID | K894213 |
| 510k Number | K894213 |
| Device Name: | SPRING LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BRANDYWINE SURGICAL, INC. P.O. BOX 25 Royersford, PA 19468 |
| Contact | Nathaniel Lieb |
| Correspondent | Nathaniel Lieb BRANDYWINE SURGICAL, INC. P.O. BOX 25 Royersford, PA 19468 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-12-11 |