WRP Asia Pacific Sdn Bhd
SALAK TINGGI, SEPANG Selangor, MY
WRP ASIA PACIFIC SDN. BHD. appears in FDA device records in SALAK TINGGI, SEPANG Selangor, MY. FDA records list 46 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 46 510(k) clearances for WRP Asia Pacific Sdn Bhd between 1999 and 2024. The busiest year on record is 2002, with 9. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 9 |
| 2003 | 5 |
| 2004 | 2 |
| 2007 | 1 |
| 2009 | 4 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | KGO | Substantially Equivalent | |
| K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | LZA | Substantially Equivalent | |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | KGO | Substantially Equivalent | |
| K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | KGO | Substantially Equivalent | |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | LYY | Substantially Equivalent | |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | LZA | Substantially Equivalent | |
| K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | KGO | Substantially Equivalent | |
| K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | LZA | Substantially Equivalent | |
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | |
| K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | |
| K133168 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | |
| K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | |
| K083410 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM | LZC | Substantially Equivalent | |
| K083408 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | |
| K083409 | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL | LZC | Substantially Equivalent | |
| K083305 | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | |
| K070619 | POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING | KGO | Substantially Equivalent | |
| K040645 | DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI | LYY | Substantially Equivalent | |
| K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR | KGO | Substantially Equivalent | |
| K032942 | PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE | KGO | Substantially Equivalent | |
| K032647 | ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA | KGO | Substantially Equivalent | |
| K032464 | ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 | KGO | Substantially Equivalent | |
| K030157 | POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM | LYY | Substantially Equivalent | |
| K023490 | DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL | LYY | Substantially Equivalent | |
| K024130 | POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE | KGO | Substantially Equivalent | |
| K023517 | DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | |
| K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | |
| K022444 | POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA | KGO | Substantially Equivalent | |
| K022442 | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) | KGO | Substantially Equivalent | |
| K021784 | PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | KGO | Substantially Equivalent | |
| K021119 | POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM | KGO | Substantially Equivalent | |
| K021159 | POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM | KGO | Substantially Equivalent | |
| K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | KGO | Substantially Equivalent | |
| K012048 | POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE | LZA | Substantially Equivalent | |
| K012135 | POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K011482 | DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | |
| K010072 | POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE | LZA | Substantially Equivalent | |
| K003653 | STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | LYY | Substantially Equivalent | |
| K002064 | COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL | LZA | Substantially Equivalent | |
| K001613 | COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | |
| K003019 | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE | KGO | Substantially Equivalent | |
| K001280 | COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES | LYY | Substantially Equivalent | |
| K000971 | PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE | KGO | Substantially Equivalent | |
| K993313 | COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE | LZA | Substantially Equivalent | |
| K993311 | COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8041005 | 3002808507 | WRP ASIA PACIFIC SDN. BHD. | LOT 1, JALAN 3, SALAK TINGGI, SEPANG Selangor 43900 MY | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GBACatheter, Balloon Type
- GBXCatheter, Irrigation
- EZLCatheter, Retention Type, Balloon
- QDOFentanyl And Other Opioid Protection Glove
- LYYLatex Patient Examination Glove
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- FMCPatient Examination Glove
- LZAPolymer Patient Examination Glove
- IWPRadiographic Protective Glove
- KGOSurgeon'S Gloves
- BTRTube, Tracheal (W/Wo Connector)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2036-2018 | AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain