Data / Medical devices / Malaysia / WRP Asia Pacific Sdn. Bhd.
WRP Asia Pacific Sdn. Bhd.: FDA-registered device maker in SALAK TINGGI, SEPANG Selangor, Malaysia, 105 510(k) clearances
WRP Asia Pacific Sdn. Bhd. is registered with the FDA (registration 8041005) in SALAK TINGGI, SEPANG Selangor, Malaysia. It lists 12 device types. The FDA files 105 510(k) clearances under its listings, the newest dated March 28, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8041005
- FEI number
- 3002808507
- Address
- Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru, SALAK TINGGI, SEPANG Selangor, Malaysia, 43900
- Owner or operator
- WRP ASIA PACIFIC SDN. BHD. (8041005)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- March 15, 1989
- Registered through
- 2026
- Brand names listed
- IRONTON DISPOSABLE PF NTR GLOVES
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 105.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2024 | 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 | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 17, 2023 | K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 31, 2023 | K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| October 22, 2022 | K222058 | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 22, 2022 | K211601 | Powder Free Latex Examination Glove, Non-Sterile | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| March 4, 2022 | K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| June 11, 2021 | K203030 | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 17, 2020 | K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 23, 2017 | K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| October 20, 2016 | K161422 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| February 5, 2015 | K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 7, 2014 | K133168 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| December 13, 2013 | K132484 | DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 18, 2011 | K111807 | MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| July 31, 2009 | K083410 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM | LZC | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| July 31, 2009 | K083408 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| July 29, 2009 | K083409 | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL | LZC | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| June 18, 2009 | K083305 | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM | LZC | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| June 27, 2007 | K070619 | POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| April 28, 2004 | K040645 | DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| March 16, 2004 | K040503 | ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| December 17, 2003 | K032942 | PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 7, 2003 | K032647 | ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 22, 2003 | K032464 | ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| February 19, 2003 | K030157 | POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 16, 2003 | K023490 | DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| December 30, 2002 | K024130 | POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| December 2, 2002 | K023517 | DERMAGRIP-P POWDER FREE PINK NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| October 3, 2002 | K022904 | DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| September 17, 2002 | K022444 | POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| September 5, 2002 | K022442 | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| July 24, 2002 | K021784 | PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 23, 2002 | K020019 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 16, 2001 | K012048 | POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| August 1, 2001 | K012135 | POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| July 9, 2001 | K011482 | DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 26, 2001 | K010072 | POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| January 26, 2001 | K003653 | STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 22, 2000 | K001613 | COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 3, 2000 | K003019 | PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| May 15, 2000 | K001280 | COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES | LYY | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| April 14, 2000 | K000971 | PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE | KGO | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 23, 1999 | K993313 | COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| November 19, 1999 | K993311 | COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE | LZA | Substantially Equivalent | Wrp Asia Pacific Sdn. Bhd. | accessdata.fda.gov |
| March 12, 1999 | K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| January 27, 1999 | K972616 | ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| January 26, 1999 | K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| October 24, 1997 | K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| October 11, 1996 | K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| July 26, 1996 | K962189 | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| July 26, 1996 | K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 6, 1996 | K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 26, 1996 | K960416 | COMFIT MICROPTIC | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 26, 1996 | K960407 | COMFIT ORTHOPEDIC | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 15, 1995 | K952154 | SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 15, 1995 | K952051 | SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 15, 1995 | K951938 | SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 11, 1995 | K952155 | SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| October 30, 1995 | K952052 | SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| October 30, 1995 | K951921 | SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) | LZA | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| July 17, 1995 | K951473 | ULTIMAX | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 17, 1995 | K951668 | SCIPOTEX/POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 17, 1995 | K951667 | COMFIT/GREEN POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 17, 1995 | K951662 | COMFIT/BEADED SURGEON'S GLOVE | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 17, 1995 | K951661 | PROFEEL | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 17, 1995 | K943601 | COMFIT (PINK) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 28, 1995 | K951468 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 28, 1995 | K951467 | ULTIMAX | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 28, 1995 | K951456 | SCIPOTEX (BLUE) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 28, 1995 | K951455 | SCIPOTEX (PINK) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 13, 1995 | K951171 | SCIPOTEX | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 13, 1995 | K951137 | COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| April 13, 1995 | K936266 | COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| March 7, 1995 | K943563 | COMFIT BLUE POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| March 7, 1995 | K943255 | SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| March 7, 1995 | K943254 | SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 24, 1995 | K943451 | ULTIMAX POWDER FREE EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 24, 1995 | K936295 | COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | Wembley Rubber Products | accessdata.fda.gov |
| February 21, 1995 | K943869 | ULTIMAX (GREEN POWDER FREE EXAMINATION) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 3, 1995 | K943868 | SCIPOTEX | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 3, 1995 | K943566 | ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 3, 1995 | K942511 | SCIPOTEX POWDER FREE EXAM GLOVES (BEADED) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 7, 1994 | K944140 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| December 7, 1994 | K936268 | COMFIT BLUE POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| November 30, 1994 | K942947 | COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| October 13, 1994 | K944141 | COMFIT (STERILE) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| August 5, 1994 | K942510 | SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 22, 1994 | K941969 | ENDOPLUS | BTR | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 22, 1994 | K936267 | COMFIT PINK POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| June 22, 1994 | K936265 | COMFIT GREEN POWDERED EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 18, 1994 | K935866 | COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 9, 1994 | K935864 | POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 9, 1994 | K935464 | COMFIT | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| March 7, 1994 | K935852 | COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC) | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| February 1, 1994 | K933263 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| January 7, 1994 | K934813 | COMFIT BLUE POWDER FREE EXAMINATION GLOVE | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| January 7, 1994 | K934812 | COMFIT GREEN POWDER FREE EXAMINATION GLOVE | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| May 11, 1993 | K922551 | SOLACE POWDER FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
| November 25, 1992 | K922515 | PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER) | KGO | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 7, 2018 | 79992 | Class II | Terminated | 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 adh | accessdata.fda.gov |
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Updated March 28, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.