Company ยท MY
Wrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2024. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2024 | K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Nov 17, 2023 | K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Aug 31, 2023 | K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Oct 22, 2022 | K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Aug 22, 2022 | K211601 | Powder Free Latex Examination Glove, Non-Sterile Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Mar 4, 2022 | K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Jun 11, 2021 | K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jan 17, 2020 | K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Jan 23, 2017 | K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Oct 20, 2016 | K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Feb 5, 2015 | K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Aug 7, 2014 | K133168 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Dec 13, 2013 | K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Jul 31, 2009 | K083410 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jul 31, 2009 | K083408 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jul 29, 2009 | K083409 | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jun 18, 2009 | K083305 | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jun 27, 2007 | K070619 | POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Apr 28, 2004 | K040645 | DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Mar 16, 2004 | K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Dec 17, 2003 | K032942 | PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Nov 7, 2003 | K032647 | ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Aug 22, 2003 | K032464 | ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Feb 19, 2003 | K030157 | POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Jan 16, 2003 | K023490 | DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Dec 30, 2002 | K024130 | POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Dec 2, 2002 | K023517 | DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Oct 3, 2002 | K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Sep 17, 2002 | K022444 | POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Sep 5, 2002 | K022442 | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jul 24, 2002 | K021784 | PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jul 5, 2002 | K021119 | POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jul 3, 2002 | K021159 | POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jan 23, 2002 | K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Aug 16, 2001 | K012048 | POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Aug 1, 2001 | K012135 | POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Jul 9, 2001 | K011482 | DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Jan 26, 2001 | K010072 | POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Jan 26, 2001 | K003653 | STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Nov 28, 2000 | K002064 | COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Nov 22, 2000 | K001613 | COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Nov 3, 2000 | K003019 | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| May 15, 2000 | K001280 | COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES Wrp Asia Pacific Sdn. Bhd., MY | LYY |
| Apr 14, 2000 | K000971 | PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd., MY | KGO |
| Nov 23, 1999 | K993313 | COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
| Nov 19, 1999 | K993311 | COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE Wrp Asia Pacific Sdn. Bhd., MY | LZA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2018 | WRP Asia Pacific Sdn Bhd AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 Terminated |
KGO | K020019 |