# Wrp Asia Pacific Sdn. Bhd.

- Location (FDA's records): Salak Tinggi, Sepang Selangor, MY
- FDA decisions: 46 (1999–2024): 46 510(k) clearances
- Product codes: KGO (20), LZA (15), LYY (6), LZC (5)
- 510(k) review time since 2016: median 183 days, against 127 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 25 (15 its own); citations of its devices by later devices: 33 (15 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wembley Rubber Products (M) Sdn Bhd: 5 (https://510kreport.com/company/wembley-rubber-products-m-sdn-bhd)
- Kossan International Sdn Bhd: 1 (https://510kreport.com/company/kossan-international-sdn-bhd)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Hi-Care Thai Gloves Co., Ltd.: 1 (https://510kreport.com/company/hi-care-thai-gloves)

## Firms that cite its devices most
- Wilshire Technologies: 2 (https://510kreport.com/company/wilshire-technologies)
- Terang Nusa Sdn Bhd: 1 (https://510kreport.com/company/terang-nusa-sdn-bhd)
- Meditech Gloves Sdn Bhd: 1 (https://510kreport.com/company/meditech-gloves-sdn-bhd)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Eco Medi Glove Sdn. Bhd.: 1 (https://510kreport.com/company/eco-medi-glove-sdn-bhd)
- Maxter Glove Manufacturing Sdn Bhd: 1 (https://510kreport.com/company/maxter-glove-manufacturing-sdn-bhd)
- Advanced Medical Products Sdn Bhd: 1 (https://510kreport.com/company/advanced-medical-products-sdn-bhd)
- Dipped Products (Thailand), Ltd.: 1 (https://510kreport.com/company/dipped-products-thailand)

## Its most-cited devices
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs (2015), cited by 7
- K022904: Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination Gloves, Non-Sterile (2002), cited by 5
- K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs (2016), cited by 3
- K133168: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile (2014), cited by 2
- K032942: Profeel Powder Free, Ploymer Coated Polyisoprene Surgical Gloves, Sterile (2003), cited by 2
- K083409: Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label (2009), cited by 2

## Recent decisions
- K232079: Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Mar 28, 2024)
- K232538: Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Nov 17, 2023)
- K230578: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Aug 31, 2023)
- K222058: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (Oct 22, 2022)
- K211601: Powder Free Latex Examination Glove, Non-Sterile (Aug 22, 2022)
- K210330: Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (Mar 4, 2022)
- K203030: Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs (Jun 11, 2021)
- K192635: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) (Jan 17, 2020)

Source page: https://510kreport.com/company/wrp-asia-pacific-sdn-bhd