Data / Medical devices / United States / Quality Packaging Specialists International, LLC

Quality Packaging Specialists International, LLC: FDA-registered device maker in Burlington, NJ, United States, 13 510(k) clearances

Name: Quality Packaging Specialists International, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Quality Packaging Specialists International, LLC is registered with the FDA (registration 3013445151) in Burlington, NJ, United States. It lists 15 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 17, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013445151
FEI number: 1000208912
Address: 2030 U.S. Highway 130, Burlington, NJ, United States, 08016
Owner or operator: Quality Packaging Specialists International (9067895)
Roles: Repackager or relabeler
First device listed: April 27, 2007
Registered through: 2026
Brand names listed: Band Aid tapes, bandages & adhesive, CONTOURED, CONTOURED ABSORBENT SHIELD, Compak Regular Scented, Compak Regular Unscented, Compak Super Scented, Compak Super Unscented, DE1LS/598/C2/1 Gentell Hydrogel Sheet Dressing 60x60mm and more

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Repackager or relabeler	accessdata.fda.gov
Cup, Menstrual	HHE	2	Repackager or relabeler	accessdata.fda.gov
Detectors And Removers, Lice, (Including Combs)	LJL	1	Repackager or relabeler	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Nursing Pad, Hydrogel	NTC	1	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Scented, Scented-Deodorized	HHL	2	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Timer, Apgar	LHB	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Repackager or relabeler	accessdata.fda.gov
Unit, Cryosurgical, Accessories	GEH	2	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
June 17, 2022	K211099	Freezen Clear Skin Clinic Warts & Tags	GEH	Substantially Equivalent	Cryoconcepts LP	accessdata.fda.gov
April 11, 2019	K190058	PureSleep (OTC use)	LRK	Substantially Equivalent	Sleep Science Partners, Inc.	accessdata.fda.gov
September 15, 2014	K141018	ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT	JEQ	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
April 23, 2014	K132595	ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
June 2, 2011	K110669	TAMPAX C PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Co.	accessdata.fda.gov
June 27, 2008	K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
May 9, 2006	K060981	PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS	HIL	Substantially Equivalent	Playtex Products, Inc.	accessdata.fda.gov
December 27, 2005	K051290	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
May 3, 2004	K040312	TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
December 6, 2002	K023789	O.B. TAMPONS	HEB	Substantially Equivalent	Mcneil-Ppc, Inc.	accessdata.fda.gov
March 22, 1984	K840679	SERENITY CONTOURED ABSORBENT SHIELDS	EYQ	Substantially Equivalent	Johnson & Johnson Consumer Products, Inc.	accessdata.fda.gov
November 16, 1979	K792195	DEODORANT CAREFREE PANTY SHIELDS	HHL	Substantially Equivalent	Personal Products Co.	accessdata.fda.gov
May 20, 1977	K770778	MAXI-PADS, STAYFREE	HHD	Substantially Equivalent	Personal Products Co.	accessdata.fda.gov

Compare with other makers

Updated June 17, 2022. 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.