The following data is part of a premarket notification filed by Medical Armor Corp. with the FDA for Protect-aids Autopsy Underglove.
| Device ID | K880440 |
| 510k Number | K880440 |
| Device Name: | PROTECT-AIDS AUTOPSY UNDERGLOVE |
| Classification | Accessory, Surgical Apparel |
| Applicant | MEDICAL ARMOR CORP. 11515 EIDELWEISS ST., N.W. Minneapolis, MN 55433 -2855 |
| Contact | Dwight K Gahm |
| Correspondent | Dwight K Gahm MEDICAL ARMOR CORP. 11515 EIDELWEISS ST., N.W. Minneapolis, MN 55433 -2855 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-02 |
| Decision Date | 1988-10-11 |