510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925077Substantially Equivalent

Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers

Medtek Development Corp., Bloomington IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925077 is the FDA 510(k) clearance record for POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS, a class II device, cleared for Medtek Development Corp. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 2 510(k) clearances for Medtek Development Corp., from to . As of , FDA records show no recalls naming K925077.

Clearance record

Decision date
Received
(313 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medtek Development Corp. 1917 E. Taylor St., Bloomington IL
510(k) summary
Statement
Third party review
No

Clearances, product code FYC

Trailing 12 months

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

FDA records show no clearances under product code FYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYC, 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