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Neil Medical Group: FDA-registered device maker in Kinston, NC, United States, 13 510(k) clearances

Name: Neil Medical Group FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neil Medical Group is registered with the FDA (registration 1058397) in Kinston, NC, United States. It lists 15 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 31, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1058397
FEI number: 1000158532
Address: 2545 Jetport Rd, Kinston, NC, United States, 28504
Owner or operator: Neil Medical Group (10090834)
Roles: Repackager or relabeler
First device listed: May 20, 2024
Registered through: 2027
Brand names listed: ENTERAL DELIVERY GRAVITY BAG W/ ENFIT, Exam Grade Blue Nitrile, Exam Grade Clear Vinyl Gloves, Exam Grade Yellow Stretch Vinyl Gloves, Isolation Gowns, Isolation Mask, Manual Wheelchair, PRE-FILLED SYRINGE and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	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
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Razor, Surgical	LWK	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Repackager or relabeler	accessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling Catheter	FCN	2	Repackager or relabeler	accessdata.fda.gov
Vinyl Patient Examination Glove	LYZ	1	Repackager or relabeler	accessdata.fda.gov
Wheelchair, Mechanical	IOR	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 31, 2025	K243441	Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)	LZA	Substantially Equivalent	Basic Medical Technology, Inc.	accessdata.fda.gov
April 17, 2024	K240039	Enteral Feeding Sets	KNT	Substantially Equivalent	Hangzhou Primecare Medical Co., Ltd.	accessdata.fda.gov
August 11, 2023	K231439	Powder Free White, Black, and Purple Nitrile Examination Glove	LZA	Substantially Equivalent	S&S Glove Corporation	accessdata.fda.gov
November 10, 2021	K210779	Powder Free Nitrile Patient Examination Gloves, Blue Color	LZA	Substantially Equivalent	Shandong Shangwei Medical Products Co., Ltd.	accessdata.fda.gov
May 14, 2021	K210780	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)	LYZ	Substantially Equivalent	Shandong Shangwei Medical Products Co., Ltd.	accessdata.fda.gov
March 30, 2021	K202708	Surgical Face Masks	FXX	Substantially Equivalent	Intco Medical(Hk) Co., Ltd.	accessdata.fda.gov
December 15, 2020	K202698	Prefilled Syringe	EZL	Substantially Equivalent	Hangzhou Primecare Medical Co., Ltd.	accessdata.fda.gov
June 27, 2017	K170735	Powder-Free Clear Vinyl Patient Examination Gloves	LYZ	Substantially Equivalent	Zibo Yue Fan Medical Products Co, Ltd.	accessdata.fda.gov
May 6, 2014	K122656	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR	LYZ	Substantially Equivalent	Shandong Yifan Plastic Products Co., Ltd.	accessdata.fda.gov
August 3, 2012	K121526	POWER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	Substantially Equivalent	Shandong Junchi Medical Products Co., Ltd.	accessdata.fda.gov
June 16, 2011	K111297	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	LYZ	Substantially Equivalent	Premier Medical Gloves Factory	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
October 5, 2005	K052468	YK9000 SERIES MANUAL WHEELCHAIR	IOR	Substantially Equivalent	Intco Metal Products (Zhenjiang) Co., Ltd.	accessdata.fda.gov

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Updated January 31, 2025. 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.