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WRP Asia Pacific Sdn. Bhd.

Active in EUDAMED

Malaysiafrom SRN EUDAMED FDA SRN MY-MF-000004690 FEI 3002808507

Devices
263
Registrations
EUDAMEDFDA
FDA recalls
1

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue263

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Company details

EUDAMED SRN
MY-MF-000004690
FDA FEI number
3002808507
EUDAMED status
Active
EUDAMED registered name
WRP Asia Pacific Sdn. Bhd.
Registered address
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA, 43900, Bandar Baru Salak Tinggi, Malaysia
Phone
+603-87061486
PRRC contact
Saravanan Ramasamy(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by WRP Asia Pacific Sdn. Bhd., initiated on 2018-05-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 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. Distribution: Distributors in AL, CA, OH, ID, KS, MN, NC, PA, TX. Submission number: K020019