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ALLIANCE RUBBER PRODUCTS SDN. BHD.

Malaysia·MY-MF-000008415

Last updated May 27, 2026

What ALLIANCE RUBBER PRODUCTS SDN. BHD. makes

Alliance Rubber Products produces nitrile and Hevea-latex examination and treatment gloves, all in non-powdered and non-antimicrobial formulations. Their portfolio includes products like Finecare, Safe Plus, Finesoft, and ARsoft, designed for medical use. These gloves are intended for direct contact with patients during clinical procedures and examinations.

The company’s gloves are classified as Class I medical devices under global regulatory frameworks. They are listed in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) registry. The manufacturer is based in Malaysia.

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

Frequently asked questions

What types of medical devices does Alliance Rubber Products Sdn. Bhd. manufacture?

Alliance Rubber Products Sdn. Bhd. specializes in manufacturing examination and treatment gloves for medical use. Their portfolio includes nitrile and Hevea-latex gloves, both in non-powdered and non-antimicrobial formulations. These gloves are designed for direct patient contact during clinical procedures and examinations, ensuring compliance with medical safety standards.

Where is Alliance Rubber Products Sdn. Bhd. based?

The company is headquartered in Malaysia, where it develops and produces its range of medical examination and treatment gloves. The Malaysian location supports its global distribution and regulatory compliance efforts.

Which regulatory registries list Alliance Rubber Products Sdn. Bhd.’s devices?

Alliance Rubber Products Sdn. Bhd.’s gloves are listed in multiple regulatory databases, including the EU’s EUDAMED system, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These listings reflect the company’s compliance with global medical device reporting requirements.

How are Alliance Rubber Products Sdn. Bhd.’s gloves classified under regulatory frameworks?

The company’s gloves are classified as Class I medical devices. This classification applies globally and reflects their low-risk profile for direct patient contact, such as examinations and treatments, where minimal risk is associated with their use.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Malaysia
Address: Lot 2716 & 2720 Mk7, Kawasan Perindustrian Bukit Panchor, Nibong Tebal, Pulau Pinang, Malaysia
Website: www.alliancerubber.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +604-5932235
PRRC Contact: Lee Beng Bee
EUDAMED SRN: MY-MF-000008415
FDA FEI Number: —
DUNS Number: 652424177

Catalogue (65)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Finecare	NGPF-04	FDA UDI	Class I	Active
Safe Plus	LGPF-04	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
Finecare	NGPF-04	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
Finecare	NGPF-04	FDA UDI	Class I	Active
Safe Plus	LGPF-04	FDA UDI	Class I	Active
ARsoft	NGPF-01	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
ARsoft	NGPF-01	FDA UDI	Class I	Active
Gold Fingers	LGPF-02	FDA UDI	Class I	Active
ARsoft	NGPF-01	FDA UDI	Class I	Active
ARsoft	NGPF-01	FDA UDI	Class I	Active
Gold Fingers	LGPF-02	FDA UDI	Class I	Active
Safe Plus	LGPF-04	FDA UDI	Class I	Active
Finecare	NGPF-04	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
ARsoft	NGPF-01	FDA UDI	Class I	Active
Finesoft	NGPF-20	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
Finecare	NGPF-04	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
Finecare	NGPF-04	FDA UDI	Class I	Active
Gold Fingers	LGPF-02	FDA UDI	Class I	Active
ARsoft	NGPF-05	FDA UDI	Class I	Active
Gold Fingers	LGPF-02	FDA UDI	Class I	Active
Safe Plus	LGPF-04	FDA UDI	Class I	Active
Alliancer Rubber ® Powdered Latex Examination Gloves, size L	LG-01	EUDAMED	Class I	Active
Latex Patient Examination Gloves	K896673	FDA 510(k)	Class I	Active
Powder Free Latex Examination Gloves With Water Extractable Protein Labeling Claim. (50 Micrograms Or Less)	K002701	FDA 510(k)	Class I	Active
Polymer Coated Powder Free Latex Examination Gloves Labeling Content: 100 Mcgm Or Less Of Total Water Extractable Protei	K992870	FDA 510(k)	Class I	Active
Nitrile Examination Gloves, Non-Sterile, Powdered, Green Color	K990485	FDA 510(k)	Class I	Active
Nitrile Examination Gloves, Powder Free, Green Color	K990453	FDA 510(k)	Class I	Active
Alliance Rubber, Ec-Grip	K972801	FDA 510(k)	Class I	Active
Nitrile Examination Gloves, Non-Sterile, Powdered, Blue Color.	K990486	FDA 510(k)	Class I	Active
Arsoft Nitrile Examination Gloves, Non-Sterile Powder Free	K990427	FDA 510(k)	Class I	Active
Finetouch ® Powder Free Nitrile Examination Gloves, Dark Blue, size M	NGPF-18DB	EUDAMED	Class I	Active
Pristine Care ® Powder Free Nitrile Examination Gloves, Accelerator-free, White, size M	NGPF-41W	EUDAMED	Class I	Active
BiEndure ® Powder Free Nitrile Examination Gloves, Blue, size XXL	NGPF-03B	EUDAMED	Class I	Active
BiProtect ® Powder Free Nitrile Examination Gloves, Blue, size M	NGPF-26B	EUDAMED	Class I	Active
Safeplus® Powder Free Latex Examination Gloves, size L	LGPF-04	EUDAMEDFDA UDI	Class I	Active
Finecare® Powder Free Nitrile Examination Gloves, Purple, size XL	NGPF-04PL	EUDAMED	Class I	Active
Finesoft ® Powder Free Nitrile Examination Gloves, Pink, size M	NGPF-20P	EUDAMED	Class I	Active
Pristine Soft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Blue, size XXL	NGPF-42B	EUDAMED	Class I	Active
ARsafe ® Powdered Nitrile Examination Gloves, Blue, size XS	NG-01B	EUDAMED	Class I	Active
Skinfit ® Powder Free Nitrile Examination Gloves, White, size M	NGPF-32W	EUDAMED	Class I	Active

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