# Eco Medi Glove Sdn. Bhd.

- Location (FDA's records): Taiping, MY
- FDA decisions: 15 (2014–2024): 15 510(k) clearances
- Product codes: LZA (14), KGO (1)
- 510(k) review time since 2016: median 129 days, against 124 for FDA's reviews in the same codes and years (7 of 11 faster)
- Predicates its devices cite: 15 (4 its own); citations of its devices by later devices: 12 (4 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
- Riverstone Resources Sdn Bhd: 6 (https://510kreport.com/company/riverstone-resources-sdn-bhd)
- Cardinal Health, Inc.: 2 (https://510kreport.com/company/cardinal-health)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Gx Corporation Sdn Bhd: 1 (https://510kreport.com/company/gx-sdn-bhd)
- Lenora Glove Pvt, Ltd.: 1 (https://510kreport.com/company/lenora-glove-pvt)

## Firms that cite its devices most
- Riverstone Resources Sdn Bhd: 3 (https://510kreport.com/company/riverstone-resources-sdn-bhd)
- Showa Best Glove, Inc.: 2 (https://510kreport.com/company/showa-best-glove)
- Shandong Baisheng Medical Products Co., Ltd.: 1 (https://510kreport.com/company/shandong-baisheng-medical-products)
- Pt. Maja Agung Latexindo: 1 (https://510kreport.com/company/pt-maja-agung-latexindo)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim (2014), cited by 3
- K161187: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (2016), cited by 2
- K141590: Emg Blue Nitrile Medical Examination Glove Powder Free (2014), cited by 2
- K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs (2017), cited by 2
- K141579: Emg Black Nitrile Medical Examination Glove Powder Free (2014), cited by 2
- K181066: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (2018), cited by 1

## Recent decisions
- K233560: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid (Feb 26, 2024)
- K232764: Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Feb 7, 2024)
- K233405: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim (Dec 28, 2023)
- K220943: Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim (Jul 19, 2022)
- K202401: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein (Feb 17, 2021)
- K193121: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (Mar 20, 2020)
- K181066: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (Sep 26, 2018)
- K171339: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs (Jul 7, 2017)

Source page: https://510kreport.com/company/eco-medi-glove-sdn-bhd