Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015727296

FEI Number

3015727296

Entity Name

UNITE MEDICAL, LLC

City/State/Country

Lithia Springs, GA, US

Establishment Address

1487 Trae Lane, Lithia Springs, GA 30122, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Unite Medical, LLC (Owner Number: 10061044)

Owner / Operator Contact Address

1487 Trae Lane, Lithia Springs, GA 30122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201284

PMA Number

N/A

All Registered Proprietary Names

medava® 3-Ply Surgical Mask Mask Portable commode chair, Toilet safety frame Unite Medical Unite Medical® Cryo Ice Pack Unite Medical medava® SoftTouch CHEMO RATED Nitrile Examination Gloves Adjustable Offset Walking Cane with Foam Handle Unite Medical Respirator Unite Medical medava® SoftTouch Nitrile Powder Free Examination Gloves Tested for Use w/ Chemotherapy Drugs and Fentanyl, (Blue) Gown;Mask medava® 4-Ply Surgical Mask Unite Medical RegeniCool Pro Cold Compression Therapy System, Total Joint Specialists medava® Procedure Mask with Ear Loops and Surgical Mask with Ties medava® Patient Nitrile Examination Gloves, Powder Free, Tested for Use w/Chemotherapy Drug medava® Blue Powder-Free Nitrile Exam Gloves, Tested For Use W/Chemotherapy Drug Sterile Hypodermic needle for Single use; Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-12-13
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-08-13
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2026-02-16
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2019-12-20
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-06-20
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2019-12-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-19
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-01-19
IPR	Crutch	Physical Medicine	Class 1	890.3150	2026-02-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-12-20
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-13
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-12-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-03-10
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-03-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-10
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-13
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-07-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2019-12-20
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-11-20
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-07-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-04-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-04-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-28

Official Correspondent

Richard Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Unite Medical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015727296. Last updated year: 2026. Please use registration number 3015727296 when referencing this establishment in official correspondence.