510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800528Substantially Equivalent

Shield Perfect Fit; Dura-Fit, Dispos.

American Convertors Div., American Pharmaseal, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800528 is the FDA 510(k) clearance record for SHIELD PERFECT FIT; DURA-FIT, DISPOS., a class I device, cleared for American Convertors Div., American Pharmaseal on under FDA product code FXP (Cover, Shoe, Operating-Room). FDA records list 19 510(k) clearances for American Convertors Div., American Pharmaseal, from to . As of , FDA records show no recalls naming K800528.

Clearance record

Decision date
Received
(40 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
American Convertors Div., American Pharmaseal 4221 Richmond Rd., NW, Walker MI
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