Data / Medical devices / United States / Purcel Labs LLC

Purcel Labs LLC: FDA-registered device maker in Los Angeles, CA, United States, 11 510(k) clearances

Name: Purcel Labs LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Purcel Labs LLC is registered with the FDA (registration 3021286079) in Los Angeles, CA, United States. It lists 15 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021286079
Address: 10537 Santa Monica Blvd. Unit 300, Los Angeles, CA, United States, 90025
Owner or operator: PurCel Labs LLC (10083940)
Roles: Repackager or relabeler
First device listed: May 13, 2023
Registered through: 2026
Brand names listed: 4mil black nitrile exam gloves, Blue Nitrile Exam Gloves (Chemo Rated), Blue Vinyl Exam Gloves, Disposable Insulin Pen Needle, Easy Result Blood Glucose Meter System, Examination Gown, Isolation Gown, Nitrile Exam chemotherapy gloves and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gown, Examination	FME	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	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
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
Vinyl Patient Examination Glove	LYZ	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
January 26, 2024	K233598	Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs	LZA	Substantially Equivalent	Anhui Intco Medical Products Co., Ltd.	accessdata.fda.gov
February 6, 2023	K223444	Powder Free Blue Nitrile Examination Glove	LZA	Substantially Equivalent	S&S Glove Corporation	accessdata.fda.gov
October 14, 2022	K213183	Safety Insulin Pen Needles	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
September 30, 2022	K222090	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
March 30, 2021	K202708	Surgical Face Masks	FXX	Substantially Equivalent	Intco Medical(Hk) Co., Ltd.	accessdata.fda.gov
March 20, 2020	K191657	Bioland Blood Glucose Monitoring System	NBW	Substantially Equivalent	Bioland Technology, Ltd.	accessdata.fda.gov
August 28, 2018	K181069	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
August 25, 2017	K170136	Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs	LZA	Substantially Equivalent	Shandong Feiyang Professional Gloves Co., Ltd.	accessdata.fda.gov
February 5, 2016	K153028	Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue	LYZ	Substantially Equivalent	Zibo Huiying Medical Products, Co. , Ltd.	accessdata.fda.gov
February 28, 2013	K123869	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	Substantially Equivalent	Dehai (Shandong) Medical Gloves, Co., Ltd.	accessdata.fda.gov
November 22, 2010	K102444	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES	LYZ	Substantially Equivalent	Zibo Yingbo Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 26, 2024. 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.