510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K971076Substantially Equivalent

Primed Shoe Covers, Primed Head Covers

Primeline Medical Products, Inc., Alberta, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971076 is the FDA 510(k) clearance record for PRIMED SHOE COVERS, PRIMED HEAD COVERS, a class I device, cleared for Primeline Medical Products, Inc. on under FDA product code FXP (Cover, Shoe, Operating-Room). FDA records list 9 510(k) clearances for Primeline Medical Products, Inc., from to . As of , FDA records show no recalls naming K971076.

Clearance record

Decision date
Received
(295 days to decision)
Product code
FXP Cover, Shoe, Operating-Room
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Primeline Medical Products, Inc. 2235-27th Ave., NE, Alberta, CA
510(k) summary
Statement
Third party review
No

Clearances, product code FXP

Trailing 12 months

FDA records hold no clearances under product code FXP in the trailing twelve months.

FDA records show no clearances under product code FXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FXP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260