Question 1

What types of medical devices does Guangdong Kingfa Sci. & Tech. Co., Ltd. manufacture?

Accepted Answer

Guangdong Kingfa Sci. & Tech. Co., Ltd. specializes in single-use medical barriers, including examination gloves made from natural latex, vinyl, and nitrile. Some of their nitrile gloves are specifically tested for use with chemotherapy drugs. They also produce disposable sterile surgical gowns and medical masks, such as surgical masks (including Level 1 and Level 3) and protective masks. These products are designed to provide protective barriers in clinical and healthcare settings.

Question 2

Where is Guangdong Kingfa Sci. & Tech. Co., Ltd. based?

Accepted Answer

The company is headquartered in China. This geographic location influences its regulatory pathways, particularly for devices marketed in regions like the European Union and the United States, where compliance with local standards is required.

Question 3

Which regulatory registries list devices from Guangdong Kingfa Sci. & Tech. Co., Ltd.?

Accepted Answer

Some of the company’s devices are listed in the EUDAMED database, which is the European Union’s transparency database for medical devices. Additionally, certain devices have been cleared through the FDA’s 510(k) pathway in the United States. These listings reflect compliance with EU Class I and Class II regulations and FDA requirements, respectively.

Question 4

How are the devices manufactured by Guangdong Kingfa Sci. & Tech. Co., Ltd. classified under EU regulations?

Accepted Answer

The company’s devices fall under EU Class I and Class II classifications. Class I devices are generally considered low-risk, such as some examination gloves and surgical masks, while Class II devices may involve a higher level of risk or require additional validation, like certain nitrile gloves tested for chemotherapy compatibility. Classification determines the regulatory scrutiny and compliance requirements each device must meet.

Question 5

Why do some of the company’s gloves include testing for chemotherapy drug compatibility?

Accepted Answer

Certain nitrile examination gloves from the company are explicitly tested for use with chemotherapy drugs due to the potential for drug permeation through glove materials. This testing ensures the gloves provide adequate protection for healthcare workers handling hazardous substances, reducing exposure risks. Such specialized testing aligns with safety standards for high-risk clinical procedures.

Device	Model / Reference	Registries	Class	Status
Natural latex examination gloves	KG-2102P(XL)	EUDAMED	Class I	Active
Vinyl examination gloves	KG-3101E(S)	EUDAMED	Class I	Active
Disposable sterile surgical gown	KF-SG A01（EO）	EUDAMED	Class I	Active
Natural latex examination gloves	KG-2102P(S)	EUDAMED	Class I	Active
Powder-Free Latex examination gloves	K222612	FDA 510(k)	Class I	Active
Medical surgical mask (Black mask, Level 1 and Level 3)	K213450	FDA 510(k)	Class II	Active
Medical Protective Mask	K202107	FDA 510(k)	Class II	Active
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs	K213040	FDA 510(k)	Class I	Active
Medical surgical mask	K233723	FDA 510(k)	Class II	Active
Medical surgical mask	K202139	FDA 510(k)	Class II	Active
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs	K222714	FDA 510(k)	Class I	Active
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs	K211220	FDA 510(k)	Class I	Active
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color	K221983	FDA 510(k)	Class I	Active
Patient Examination Gloves	K203593	FDA 510(k)	Class I	Active
Medical surgical mask	K201622	FDA 510(k)	Class II	Active
Biodegradable Medical surgical mask	K231155	FDA 510(k)	Class II	Active
Nitrile examination gloves	KG-1802	EUDAMED	Class I	Active
Disposable sterile medical mask	KF-B P09(WK-EO)	EUDAMED	Class I	Active
Natural latex examination gloves	KG-2102P(XS)	EUDAMED	Class I	Active
Premium Adult Diapers	KMP-C32	EUDAMED	Class I	Active
Vinyl examination gloves	KG-3101E(XL)	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1303	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1802	EUDAMED	Class I	Active
Nitrile examination gloves	KS-ST RT021	EUDAMED	Class I	Active
Disposable sterile examination glove	KG-2101E	EUDAMED	Class I	Active
Disposable sterile medical mask	KF-B P01(WK-EO)	EUDAMED	Class I	Active
Natural latex examination gloves	KG-2102P(L)	EUDAMED	Class I	Active
Disposable sterile medical mask	KF-B P01(WK-BD-EO)	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1303	EUDAMED	Class I	Active
Disposable sterile medical mask	KF-B P09(WK-BD-EO)	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1303	EUDAMEDFDA 510(k)	Class I	Active
Absorbent Underpad	KMP-A31	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1802	EUDAMED	Class I	Active
Natural latex examination gloves	KG-2102P(XS)	EUDAMED	Class I	Active
Vinyl examination gloves	KG-3101E(M)	EUDAMED	Class I	Active
Natural latex examination gloves	KG-2102P(M)	EUDAMED	Class I	Active
Nitrile examination gloves	KG-1303	EUDAMED	Class I	Active
Vinyl examination gloves	KG-3101E(L)	EUDAMED	Class I	Active
Nitrile Examination Gloves	KG-1802	EUDAMED	Class I	Active
Nitrile Examination Gloves	KG-1101	EUDAMED	Class I	Active

GUANGDONG KINGFA SCI. & TECH. CO., LTD.

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