# Yty Industry (Manjung) Sdn Bhd

- Location (FDA's records): Sparks, NV
- FDA decisions: 28 (1989–2026): 28 510(k) clearances
- Product codes: LZA (17), LYY (10), LZC (1)
- 510(k) review time since 2016: median 134 days, against 111 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 15 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shield Gloves Manufacturer (M) Sdn Bhd: 3 (https://510kreport.com/company/shield-gloves-manufacturer-m-sdn-bhd)
- Sgmp Co., Ltd.: 1 (https://510kreport.com/company/sgmp)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Hartalega NGC Sdn. Bhd.: 1 (https://510kreport.com/company/hartalega-ngc-sdn-bhd)
- Maxxim Medical: 1 (https://510kreport.com/company/maxxim-medical)
- Brightway Holdings Sdn. Bhd.: 1 (https://510kreport.com/company/brightway-holdings-sdn-bhd)
- Supergrade Healthcare Products Sdn. Bhd.: 1 (https://510kreport.com/company/supergrade-healthcare-products-sdn-bhd)

## Firms that cite its devices most
- Mexpo International, Inc.: 1 (https://510kreport.com/company/mexpo-international)
- Aamedix Glove Sdn Bhd: 1 (https://510kreport.com/company/aamedix-glove-sdn-bhd)
- Shandong Huiwosheng Health Technology Co.,Ltd: 1 (https://510kreport.com/company/shandong-huiwosheng-health-technology)
- Pt. Shamrock Manufacturing Corpora: 1 (https://510kreport.com/company/pt-shamrock-manufacturing-corpora)
- Onetexx Sdn Bhd: 1 (https://510kreport.com/company/onetexx-sdn-bhd)
- Safeskin Retailing (Hk) Limited: 1 (https://510kreport.com/company/safeskin-retailing-hk)
- Worldmed Manufacturing Sdn. Bhd.: 1 (https://510kreport.com/company/worldmed-manufacturing-sdn-bhd)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K143289: Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color (2015), cited by 4
- K052502: Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves (2005), cited by 3
- K111248: Non-Sterile, Powder-Free Nitrile Examination Gloves (Original Blue, Cobalt Blue) (2011), cited by 2
- K974191: Evergreen Non-Sterile Powdered Latex Examination Glove (1997), cited by 2
- K061553: Non-Sterile, Powder-Free Black Nitrile Examination Gloves (2006), cited by 1
- K023590: Powdered Natural and/or Colored Latex Exam Gloves (2002), cited by 1

## Recent decisions
- 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 (Oct 1, 2026)
- K220644: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs (Mar 25, 2023)
- 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 (Aug 11, 2021)
- K200453: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-AC (May 1, 2020)
- K182383: Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue (Mar 19, 2019)
- K171104: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) (Aug 25, 2017)
- K162095: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) (Nov 2, 2016)
- K143289: Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color (Aug 18, 2015)

Source page: https://510kreport.com/company/yty-industry-manjung-sdn-bhd