510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003749Substantially Equivalent

100% 30G Polypropylene Spunbond Islation Grown

Banta Healthcare, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003749 is the FDA 510(k) clearance record for 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN, a class II device, cleared for Banta Healthcare on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list one 510(k) clearance for Banta Healthcare. As of , FDA records show no recalls naming K003749.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Banta Healthcare P.O. Box 4341, Crofton MD
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