The following data is part of a premarket notification filed by F & L Medical Products Co. with the FDA for Attenuating Surgical Glove.
| Device ID | K891315 |
| 510k Number | K891315 |
| Device Name: | ATTENUATING SURGICAL GLOVE |
| Classification | Patient Examination Glove, Specialty |
| Applicant | F & L MEDICAL PRODUCTS CO. P.O. BOX 165 Leechburg, PA 15656 |
| Contact | Fred S Foust |
| Correspondent | Fred S Foust F & L MEDICAL PRODUCTS CO. P.O. BOX 165 Leechburg, PA 15656 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-13 |
| Decision Date | 1989-10-05 |