Data / Medical devices / Malaysia / Yty Industry (manjung) Sdn. Bhd.
Yty Industry (manjung) Sdn. Bhd.: FDA-registered device maker in SITIAWAN Perak, Malaysia, 21 510(k) clearances
Yty Industry (manjung) Sdn. Bhd. is registered with the FDA (registration 9613997) in SITIAWAN Perak, Malaysia. It lists 4 device types. The FDA files 21 510(k) clearances under its listings, the newest dated October 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613997
- FEI number
- 3002563423
- Address
- Lot 1422-1424, Batu 10 Lekir, SITIAWAN Perak, Malaysia, 32020
- Owner or operator
- YTY INDUSTRY SDN BHD (8041009)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 28, 2008
- Registered through
- 2027
- Brand names listed
- BISM Critical Response Nitrile Exam Gloves, CR911, CUR9311, CURAD Versatile, Critical Response, Critical Response High Visibility Gloves, EZDoff, EZDoffy and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 2026 | K262208 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| September 27, 2024 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 25, 2023 | K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| August 11, 2021 | K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| October 26, 2020 | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) | LZA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| September 18, 2020 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | LZC | Substantially Equivalent | Medline Industires, Inc. | accessdata.fda.gov |
| August 4, 2020 | K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff | LZA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 8, 2019 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| August 25, 2017 | K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| November 2, 2016 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| January 16, 2015 | K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| May 30, 2014 | K133123 | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| March 9, 2012 | K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| December 1, 2011 | K111248 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | 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 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | LZC | Substantially Equivalent | Kimberly-Clark | accessdata.fda.gov |
| July 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 23, 1999 | K990013 | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated October 1, 2026. 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.