The following data is part of a premarket notification filed by Medical Armor Corp. with the FDA for Medarmor Finger Tip, Puncture Resistant Underglove.
| Device ID | K923229 |
| 510k Number | K923229 |
| Device Name: | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE |
| Classification | Accessory, Surgical Apparel |
| Applicant | MEDICAL ARMOR CORP. 925 WEST 6TH ST. Fremont, NE 68025 |
| Contact | Dwigh K Gahm |
| Correspondent | Dwigh K Gahm MEDICAL ARMOR CORP. 925 WEST 6TH ST. Fremont, NE 68025 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-05-07 |