510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954549Substantially Equivalent

Surgical Apparel

Global Healthcare, Inc., Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954549 is the FDA 510(k) clearance record for SURGICAL APPAREL, a class II device, cleared for Global Healthcare, Inc. on under FDA product code FYC (Gown, Isolation, Surgical). FDA records list 3 510(k) clearances for Global Healthcare, Inc., from to . As of , FDA records show no recalls naming K954549.

Clearance record

Decision date
Received
(199 days to decision)
Product code
FYC Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Global Healthcare, Inc. 2110 Federal Rd., Roswell GA
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