Global Healthcare, Inc.

Atlanta, GA, US

Global Healthcare, Inc. appears in FDA device records in Atlanta, GA. FDA records list 3 510(k) clearances between 1996-01-26 and 1999-04-05, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 2 recalls for this company.

510(k) clearances: 3
PMA records: 0
Recall records: 2
Registered establishments: 0

510(k) clearance history

FDA records hold 3 510(k) clearances for Global Healthcare, Inc. between 1996 and 1999. The busiest year on record is 1996, with 2. The most recent is 1999, with 1.

Clearances by year, as a table

510(k) clearance decisions for Global Healthcare, Inc., by decision year
Year	Clearances
1996	2
1999	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K990567	GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH	FRG	Substantially Equivalent	1999-04-05
K954549	SURGICAL APPAREL	FYC	Substantially Equivalent	1996-04-18
K953754	GLOBAL HEALTHCARE FACE MASK	FXX	Substantially Equivalent	1996-01-26

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2870-2016	MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.	The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.	Class II	2016-08-09	Terminated
Z-0696-2016	ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China	Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.	Class II	2016-01-06	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain