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WRP Asia Pacific Sdn. Bhd.

Malaysia MY-MF-000004690 Last updated 23 Oct 2026

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Devices
260
Registries
EUDAMEDFDA 510(k)FDA
FDA recalls
1

Catalogue260

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Showing 1-50 of 260

Authorised representatives

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2018

    • 7 May 2018 Z-2036-2018 Class II Terminated Some left-handed gloves contain powder. Powdered surgical gloves are a banned medical device in the U.S. Powder on natural rubber latex gloves can aerosolize latex allergens, resulting in sensitization to latex and allergic reactions. Additional risks of powdered gloves include severe airway inflammation, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.

What WRP Asia Pacific Sdn. Bhd. makes

WRP Asia Pacific Sdn. Bhd. manufactures a range of medical gloves, including sterile and powder-free options, made from materials such as natural rubber latex and nitrile. These gloves are designed for surgical use and some are tested for use with chemotherapy drugs and fentanyl. The company's products include the Dermagrip and Epic N brands.

The company's portfolio is regulated under Class I and Class IIa device classes and is listed in the Eudamed and FDA 510(k) registries. WRP Asia Pacific Sdn. Bhd. 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 type of products does WRP Asia Pacific Sdn. Bhd. manufacture?

WRP Asia Pacific Sdn. Bhd. manufactures medical gloves, including sterile and powder-free options, made from materials such as natural rubber latex and nitrile, designed for surgical use.

Where is WRP Asia Pacific Sdn. Bhd. based?

The company is based in Malaysia, as indicated by its country code MY.

Which registries list WRP Asia Pacific Sdn. Bhd.'s devices?

The company's devices are listed in the Eudamed and FDA 510(k) registries, which track medical devices.

How are WRP Asia Pacific Sdn. Bhd.'s devices classified?

The company's devices are classified under Class I and Class IIa, indicating their level of risk and regulatory control.

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

Information

Country
Malaysia
Address
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA , Bandar Baru Salak Tinggi, Malaysia
Phone
+603-87061486
PRRC contact
Saravanan Ramasamy
EUDAMED SRN
MY-MF-000004690
FDA FEI number
3002808507