Question 1

What types of medical devices does SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED primarily manufacture?

Accepted Answer

SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED specializes in non-sterile, powder-free examination and treatment gloves. Their products include both hevea-latex gloves (such as *Sri Trang Gloves Verve* and *Vigor*) and nitrile gloves (like *AURON* and *Viva Chemo Plus*). Some variants are specifically tested for compatibility with chemotherapy drugs and fentanyl, ensuring safer use in sensitive medical procedures.

Question 2

Where is SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED based?

Accepted Answer

The company is headquartered in Thailand, where it designs and manufactures its range of medical gloves. The location is relevant for regulatory compliance, supply chain logistics, and understanding the regional market focus of their products.

Question 3

Which regulatory registries list devices manufactured by SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED?

Accepted Answer

Devices from SRI TRANG GLOVES are listed in key regulatory databases, including EUDAMED (for EU market surveillance), FDA’s 510(k) (for premarket notifications in the US), and FDA’s UDI system (for unique device identification). These registries help healthcare providers and regulators track compliance and device authorisation status.

Question 4

How are the gloves produced by SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED classified under medical device regulations?

Accepted Answer

All gloves manufactured by SRI TRANG GLOVES fall under Class I medical device classification. This classification applies to low-risk devices like non-sterile, powder-free gloves, which typically require less stringent regulatory oversight compared to higher-risk categories. The classification is determined by factors like intended use, risk, and potential harm to patients.

Device	Model / Reference	Registries	Class	Status
Cmt	10501	EUDAMED	Class I	Active
Luvas	125634	EUDAMED	Class I	Active
Sri Trang Gloves Viva Lite Nitrile Powder-Free Examination Gloves	DNOFLOG	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Nitrilo Sin Polvo	LM-GDNIT-AZ-DLSP-S	EUDAMED	Class I	Active
Luvas	63369	EUDAMED	Class I	Active
Cmt	3031	EUDAMED	Class I	Active
Sri Trang Gloves Vigor Latex Powdered Examination Gloves	DLXFSOG	EUDAMED	Class I	Active
Sri Trang Gloves Viva Latex Powder-Free Examination Gloves	DLOFBOG	EUDAMED	Class I	Active
peppler sensitive edition	209A	EUDAMED	Class I	Active
Sentina Ivory Latex	163042	EUDAMED	Class I	Active
Cmt	6600	EUDAMED	Class I	Active
Smart	3160165	EUDAMED	Class I	Active
Favorit Edition	33006	EUDAMED	Class I	Active
Sri Trang Gloves Viva Nitrile Powder-Free Examination Gloves	DNOFEOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Nitrile Powder-Free Examination Gloves	DNOFSOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powdered Examination Gloves	DRXFBOG	EUDAMED	Class I	Active
Sri Trang Gloves Viva Nitrile Powder-Free Examination Gloves	DNOFEOG	EUDAMED	Class I	Active
Cmt	8501	EUDAMED	Class I	Active
Smart	3160163	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DLOFSOG	EUDAMED	Class I	Active
Smart	3160165	EUDAMED	Class I	Active
FLEXCEL LATEX GLOVES Powder Free	GL229S	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Sin Polvo	LM-GDLTX-BL-BASP-M	EUDAMED	Class I	Active
Sri Trang Gloves Viva Nitrile Powder-Free Examination Gloves	DNOFEOG	EUDAMED	Class I	Active
Sri Trang Gloves Vigor Latex Powdered Examination Gloves	DLXFSOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powdered Examination Gloves	DRXFBOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Spectrum Latex Powder-Free Examination Gloves	DRCFCOG	EUDAMED	Class I	Active
Hoz	HOZ XL	EUDAMED	Class I	Active
Cuatrogasa Guantes De Examen Desechables De Latex Con Polvo	CU-GDLTX-BL-BACP-M	EUDAMED	Class I	Active
Peha-Soft® Latex Protect XL	942010	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DRCFSOG	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Sin Polvo	LM-GDLTX-BL-BASP-XL	EUDAMED	Class I	Active
Essentials	572-4332	EUDAMED	Class I	Active
Sentina Ambidextrous NP Latex	141391	EUDAMED	Class I	Active
Cuatrogasa Guantes De Examen Desechables De Latex Con Polvo	CU-GDLTX-BL-BACP-XS	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Nitrilo Sin Polvo	LM-GDNIT-AZ-DLSP-L	EUDAMED	Class I	Active
ALUMINIUM Thalassinos Latex Examination Gloves	EM.5485	EUDAMED	Class I	Active
Sri Trang Gloves Viva Lite Nitrile Powder-Free Examination Gloves	DNOFLOG	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Sin Polvo	LM-GDLTX-BL-BASP-L	EUDAMED	Class I	Active
Smart	3160162	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DLCFSOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powdered Examination Gloves	DRXFBOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DROFSOG	EUDAMED	Class I	Active
Peha-Soft® Latex Protect M	942008	EUDAMED	Class I	Active
Peha-Soft® Latex Protect XS	942006	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DLOFSOG	EUDAMED	Class I	Active
Sri Trang Gloves Verve Spectrum Latex Powder-Free Examination Gloves	DLCFCOG	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Sin Polvo	LM-GDLTX-BL-BASP-XS	EUDAMED	Class I	Active
Sri Trang Gloves Viva Latex Powder-Free Examination Gloves	DLOFBOG	EUDAMED	Class I	Active
Cybertech	572-4335	EUDAMED	Class I	Active

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