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
Linea Medica Guantes De Examen De Nitrilo Sin Polvo	LM-GDNIT-AZ-DLSP-M	EUDAMED	Class I	Active
Latex Examination Glove Powder Free (Ocean Blue and Natural White)	K240266	FDA 510(k)	Class I	Active
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster	K193581	FDA 510(k)	Class I	Active
Sri Trang Gloves Vigor Latex Powder-Free Examination Gloves	DLCFSLT	EUDAMED	Class I	Active
Peha-Soft® Latex Comfort XS	9420200	EUDAMED	Class I	Active
Sri Trang Gloves Viva Latex Powder-Free Examination Gloves	DLOFBOG	EUDAMED	Class I	Active
Smart	3160162	EUDAMED	Class I	Active
Favorit Edition	33010	EUDAMED	Class I	Active
Manufix Sensitive	9209430	EUDAMED	Class I	Active
PharmaDanica	PharmaDanica L	EUDAMED	Class I	Active
Cybertech	572-4336	EUDAMED	Class I	Active
Favorit Edition	33008	EUDAMED	Class I	Active
Vasco Sensitive	6067565	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Nitrilo Sin Polvo	LM-GDNIT-AZ-DLSP-XL	EUDAMED	Class I	Active
Cuatrogasa Guantes De Examen Desechables De Latex Sin Polvo	CU-GDLTX-BL-BASP-XL	EUDAMED	Class I	Active
Luvas	233635	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Sin Polvo	LM-GDLTX-BL-BASP-S	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Nitrilo Sin Polvo	LM-GDNIT-AZ-DLSP-XS	EUDAMED	Class I	Active
Sammar	SAMMAR03190	EUDAMED	Class I	Active
Vasco Sensitive	6067590	EUDAMED	Class I	Active
Linea Medica Guantes De Examen De Latex Con Polvo	LATEXPLXS	EUDAMED	Class I	Active
Cybertech	572-4334	EUDAMED	Class I	Active
FLEXCEL Pro Blue Nitrile Gloves Powder Free	GL288L	EUDAMED	Class I	Active
Sentina Ivory Latex	163041	EUDAMED	Class I	Active
Peha-Soft® Latex Comfort L	9420230	EUDAMED	Class I	Active
Cmt	7501	EUDAMED	Class I	Active
Cmt	7700	EUDAMED	Class I	Active
Hoz	HOZ M	EUDAMED	Class I	Active
Vasco Sensitive	6067500	EUDAMED	Class I	Active
Bycliniclic	BY-GDLTX-BL-BASP-XS	EUDAMED	Class I	Active
Cmt	3035	EUDAMED	Class I	Active
Sammar	SAMMAR04190	EUDAMED	Class I	Active
Favorit Edition	33007	EUDAMED	Class I	Active
Manufix Sensitive	9209499	EUDAMED	Class I	Active
PharmaDanica	PharmaDanica M	EUDAMED	Class I	Active
Cybertech	572-4337	EUDAMED	Class I	Active
Cmt	5500	EUDAMED	Class I	Active
Cmt	3033	EUDAMED	Class I	Active
Bycliniclic	BY-GDLTX-BL-BASP-S	EUDAMED	Class I	Active
Sentina Ivory Latex	163040	EUDAMED	Class I	Active
Smart	3160163	EUDAMED	Class I	Active
peppler sensitive lotus	208	EUDAMED	Class I	Active
Bycliniclic	BY-GDLTX-BL-BASP-M	EUDAMED	Class I	Active
Sri Trang Gloves Verve Latex Powder-Free Examination Gloves	DRCFSOG	EUDAMED	Class I	Active
Cuatrogasa Guantes De Examen Desechables De Latex Sin Polvo	CU-GDLTX-BL-BASP-L	EUDAMED	Class I	Active
Luvas	78564	EUDAMED	Class I	Active
Cmt	4400	EUDAMED	Class I	Active
Sri Trang Gloves Viva Lite Nitrile Powder-Free Examination Gloves	DNOFLOG	EUDAMED	Class I	Active
Peha-Soft® Latex Comfort S	9420210	EUDAMED	Class I	Active
Peha-Soft® Latex Protect L	942009	EUDAMED	Class I	Active

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