Q: What types of medical devices does Jiangsu Guangda Medical Material, Co., Ltd. manufacture?

Jiangsu Guangda Medical Material, Co., Ltd. specializes in producing surgical gowns made from SMS (spunbond-meltblown-spunbond) nonwoven fabric. These gowns are designed for single-use in clinical and procedural environments to create a barrier against fluids and contaminants, ensuring patient and user safety during medical procedures.

Question 1

What types of medical devices does Jiangsu Guangda Medical Material, Co., Ltd. manufacture?

Accepted Answer

Jiangsu Guangda Medical Material, Co., Ltd. manufactures surgical gowns made from SMS (spunbond-meltblown-spunbond) nonwoven fabric, designed for single-use in clinical and procedural settings to provide barrier protection against fluids and contaminants.

The company’s SMS surgical gowns are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Jiangsu Guangda Medical Material, Co., Ltd. based?

Accepted Answer

The company operates from the United States, though its manufacturing origins may trace back to its original location in China. The U.S. presence allows it to comply with local regulatory requirements and distribute its products in North American markets.

Question 3

How are Jiangsu Guangda’s surgical gowns classified under FDA regulations?

Accepted Answer

Jiangsu Guangda’s SMS surgical gowns are classified as Class II devices by the FDA. This classification is determined based on their intended use—providing a fluid-resistant barrier in surgical settings—which requires special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.

Question 4

Which regulatory registries or databases list Jiangsu Guangda’s medical devices?

Accepted Answer

Jiangsu Guangda’s surgical gowns are listed in the FDA’s 510(k) database, a registry that tracks devices cleared through the 510(k) pathway. This listing confirms that the company has submitted documentation demonstrating compliance with FDA requirements for Class II devices, though it does not imply approval of the company itself—only that the specific device has met regulatory criteria for market authorization.

Device	Model / Reference	Registries	Class	Status
Gd	BB3040	FDA UDI	Class I	Active
Gd	7-9600	FDA UDI	Class I	Active
Gd	291212PW-X	FDA UDI	Class I	Active
Gd	101727B	FDA UDI	Class II	Active
Gd	121727W-1.5	FDA UDI	Class II	Active
Gd	UT4545	FDA UDI	Class II	Active
Gd	641137-3	FDA UDI	Class I	Active
Gd	211836PWNB	FDA UDI	Class I	Active
Gd	7-9603	FDA UDI	Class I	Active
Gd	211212PWNB	FDA UDI	Class I	Active
Gd	101830B	FDA UDI	Class II	Active
Gd	101727BX	FDA UDI	Class II	Active
Gd	211818PW	FDA UDI	Class I	Active
Gd	231818PWNL	FDA UDI	Class I	Active
Gd	101727G	FDA UDI	Class II	Active
Gd	101727W	FDA UDI	Class II	Active
Gd	101830UW	FDA UDI	Class II	Active
Gd	362204-10	FDA UDI	Class I	Active
Gd	UT5472	FDA UDI	Class II	Active
Gd	221818PWR	FDA UDI	Class I	Active
Gd	4-4130-G	FDA UDI	Class I	Active
Gd	363304-10	FDA UDI	Class I	Active
Gd	511-006	FDA UDI	Class I	Active
Gd	UT5454	FDA UDI	Class II	Active
Gd	511-005	FDA UDI	Class I	Active
Gd	121713B-1.5	FDA UDI	Class II	Active
Gd	UT2727	FDA UDI	Class II	Active
Gd	291818PW-X	FDA UDI	Class I	Active
Gd	364404-10	FDA UDI	Class I	Active
Gd	201818UW	FDA UDI	Class I	Active
GD Disposable Medical Face Mask	K201718	FDA 510(k)	Class II	Active
Surgical Gown, Sms	K121152	FDA 510(k)	Class II	Active

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