510(k) Report

FDA applicant

Wrp Specialty Products Sdn. Bhd.

Selangor Daurl Ehsan, Sepang, MY18 decisions1999–20040 recalls

FDA records 18 decisions for Wrp Specialty Products Sdn. Bhd. (Selangor Daurl Ehsan, Sepang, MY) from 1999 to 2004: 18 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Wrp Specialty Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wrp Specialty Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wrp Specialty Products Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wrp Specialty Products Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove12decisions
  • LZAPolymer Patient Examination Glove3decisions
  • KGOSurgeon'S Gloves3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022808Dermagrip Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 UG or…Wrp Specialty Products Sdn. Bhd. · 20021cites it

What has FDA decided for it lately?

  • K032016Dermagrip-X Powder Free Latex Examination Gloves Coated with Alpha Lipoic Acid and Vitamin E, and with…Wrp Specialty Products Sdn. Bhd. · 2004
  • K022808Dermagrip Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 UG or…Wrp Specialty Products Sdn. Bhd. · 2002
  • K021561Dermagrip and Multiple Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim (50…Wrp Specialty Products Sdn. Bhd. · 2002
  • K021536Dermagrip and Multiple Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim…Wrp Specialty Products Sdn. Bhd. · 2002
  • K021396Dermagrip and Multiple Powder Free Purple Nitrile Examination Gloves, Non-SterileWrp Specialty Products Sdn. Bhd. · 2002
  • K014288Dermgrip Powder Free Polymer Coated Latex Surgeon's Gloves,Sterile with Protein Content Labeling Claim (50…Wrp Specialty Products Sdn. Bhd. · 2002
  • K013942Powder Free Blue Latex Examination Glove, Non-Sterile (Protein Content Labeling)Wrp Specialty Products Sdn. Bhd. · 2001
  • K012876Dermagrip Powder Free Latex Examination Gloves with Aloe Vera Protein Content Labeling Claim (50 Micrograms…Wrp Specialty Products Sdn. Bhd. · 2001

All 18 as Wrp Specialty Products Sdn. Bhd. →