510(k) Report

FDA applicant

Eco Medi Glove Sdn. Bhd.

Taiping, MY15 decisions2014–20240 recalls

FDA records 15 decisions for Eco Medi Glove Sdn. Bhd. (Taiping, MY) from 2014 to 2024: 15 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Eco Medi Glove Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2014: 42016: 32017: 12018: 12020: 12021: 12022: 12023: 12024: 2
2014high 4 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Eco Medi Glove Sdn. Bhd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eco Medi Glove Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove14decisions
  • KGOSurgeon'S Gloves1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 7 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd. · 20143cite it
  • K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy DrugsEco Medi Glove Sdn. Bhd. · 20162cite it
  • K141590Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 20142cite it
  • K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy DrugsEco Medi Glove Sdn. Bhd. · 20172cite it
  • K141579Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 20142cite it
  • K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with…Eco Medi Glove Sdn. Bhd. · 20181cites it

What has FDA decided for it lately?

  • K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with…Eco Medi Glove Sdn. Bhd. · 2024
  • K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl…Eco Medi Glove Sdn. Bhd. · 2024
  • K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd. · 2023
  • K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimEco Medi Glove Sdn. Bhd. · 2022
  • K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per…Eco Medi Glove Sdn. Bhd. · 2021
  • K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with…Eco Medi Glove Sdn. Bhd. · 2020
  • K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with…Eco Medi Glove Sdn. Bhd. · 2018
  • K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy DrugsEco Medi Glove Sdn. Bhd. · 2017

All 15 as Eco Medi Glove Sdn. Bhd. →