Data / Medical devices / United States / Priority Environmental Solutions

Priority Environmental Solutions: FDA-registered device maker in Hartland, WI, United States, 3 510(k) clearances

Name: Priority Environmental Solutions FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Priority Environmental Solutions is registered with the FDA (registration 3008298053) in Hartland, WI, United States. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 10, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008298053
Address: 710 Rose Dr, Hartland, WI, United States, 53029
Owner or operator: Priority Environmental Solutions, Inc (10033976)
Roles: Repackager or relabeler
First device listed: September 10, 2018
Registered through: 2026
Brand names listed: Cat Tourniquet, Compressed Gauze, Flat Emergency Trauma Dressing, Gauze, Hyfin Dual Pack, Kit, Lube 1250 Dynalube, M2 Ratcheting Medical Tourniquet and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Compression	MHW	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Repackager or relabeler	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Solvent, Adhesive Tape	KOX	1	Repackager or relabeler	accessdata.fda.gov
Suit, Surgical	FXO	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 10, 2017	K170397	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Kossan International Sdn Bhd	accessdata.fda.gov
August 3, 2016	K151750	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile	LZA	Substantially Equivalent	Kossan International Sdn Bhd	accessdata.fda.gov
November 24, 2014	K140573	WOUNDCLOT HEMOSTATIC GAUZE	QSY	Substantially Equivalent	Core Scientific , Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 10, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.