The following data is part of a premarket notification filed by Medical Armor Corp. with the FDA for Medarmor Fingertip, Punc/cut Resist Surg Exam Glov.
| Device ID | K912737 |
| 510k Number | K912737 |
| Device Name: | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV |
| Classification | Accessory, Surgical Apparel |
| Applicant | MEDICAL ARMOR CORP. P.O. BOX 708 Fremont, MD 68025 |
| Contact | Dwight K Gahm |
| Correspondent | Dwight K Gahm MEDICAL ARMOR CORP. P.O. BOX 708 Fremont, MD 68025 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-21 |
| Decision Date | 1991-10-08 |