510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982369Substantially Equivalent

Convertors, Spunbonded, Flashspun Polyolefin Gowns

Medtronic, Inc., Mcgraw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982369 is the FDA 510(k) clearance record for CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS, a class II device, cleared for Allegiance Healthcare Corp. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K982369.

Clearance record

Decision date
Received
(48 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Allegiance Healthcare Corp. 1500 Waukegan Rd.- K, Mcgraw Park IL
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260