510(k) Report

FDA applicant

Central Medicare Sdn Bhd

Teluk Intan, MY15 decisions2010–20230 recalls

FDA records 15 decisions for Central Medicare Sdn Bhd (Teluk Intan, MY) from 2010 to 2023: 15 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 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 Central Medicare Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

4in 2023

2010: 12011: 12012: 12015: 12017: 22018: 12019: 12021: 22022: 12023: 4
2010high 4 (2023) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Central Medicare Sdn Bhd by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Central Medicare 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 Glove11decisions
  • LZCMedical Glove, Specialty4decisions

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 5 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.

  • K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd · 20175cite it
  • K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd · 20182cite it
  • K103734Powder Free Nitrile Examination Gloves White Colored Non-SterileCentral Medicare Sdn Bhd · 20112cite it
  • K093696SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803Central Medicare Sdn Bhd · 20102cite it
  • K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 20172cite it
  • K203036Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)Central Medicare Sdn Bhd · 20211cites it

What has FDA decided for it lately?

  • K230681Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric…Central Medicare Sdn Bhd · 2023
  • K223752Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with…Central Medicare Sdn Bhd · 2023
  • K230875Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric…Central Medicare Sdn Bhd · 2023
  • K230564Green Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2023
  • K213437Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric…Central Medicare Sdn Bhd · 2022
  • K211022Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with…Central Medicare Sdn Bhd · 2021
  • K203036Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)Central Medicare Sdn Bhd · 2021
  • K183149Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl…Central Medicare Sdn Bhd · 2019

All 15 as Central Medicare Sdn Bhd →