510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K922442Substantially Equivalent

Isolation Gowns

Pfb Inter-Apparel Corp., Medley FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922442 is the FDA 510(k) clearance record for ISOLATION GOWNS, a class II device, cleared for Pfb Inter-Apparel Corp. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 2 510(k) clearances for Pfb Inter-Apparel Corp., from to . As of , FDA records show no recalls naming K922442.

Clearance record

Decision date
Received
(508 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Pfb Inter-Apparel Corp. 8751 NW 102nd St., Medley FL
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