Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030419987

FEI Number

3030419987

Entity Name

GCB MEDICAL LLC

City/State/Country

Duxbury, MA, US

Establishment Address

25 Depot St, Duxbury, MA 02332, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GCB Medical LLC (Owner Number: 10090007)

Owner / Operator Contact Address

25 Depot St, Duxbury, MA 02332, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170136

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-07-29
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-07-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-01
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	Class 1	890.5710	2025-07-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-08-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-07-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-07-01
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-07-01
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-07-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-02-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-02-23

Official Correspondent

Jeff Willink

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GCB 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
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
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030419987. Last updated year: 2026. Please use registration number 3030419987 when referencing this establishment in official correspondence.