510(k) Report

FDA applicant

Careplus (M) Sdn Bhd

Seremban, MY10 decisions2015–20210 recalls

FDA records 10 decisions for Careplus (M) Sdn Bhd (Seremban, MY) from 2015 to 2021: 10 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 207 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Careplus (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

6in 2021

2015: 22016: 12017: 12021: 6
2015high 6 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Careplus (M) Sdn Bhd by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • KGOSurgeon'S Gloves4decisions
  • LZAPolymer Patient Examination Glove3decisions
  • LYYLatex Patient Examination Glove2decisions
  • LZCMedical Glove, Specialty1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 207 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 194 days; 3 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K152593Latex Examination Glove Powder FreeCareplus (M) Sdn Bhd · 20162cite it
  • K142862POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 20152cite it
  • K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or…Careplus (M) Sdn Bhd · 20211cites it
  • K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)Careplus (M) Sdn Bhd · 20151cites it
  • K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 20211cites it
  • K162858Nitrilecare Nitrile Examination Gloves Powder Free, Blue, ChemotestCareplus (M) Sdn Bhd · 20171cites it

What has FDA decided for it lately?

  • K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)Careplus (M) Sdn Bhd · 2021
  • K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total…Careplus (M) Sdn Bhd · 2021
  • K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021
  • K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per…Careplus (M) Sdn Bhd · 2021
  • K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per…Careplus (M) Sdn Bhd · 2021
  • K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or…Careplus (M) Sdn Bhd · 2021
  • K162858Nitrilecare Nitrile Examination Gloves Powder Free, Blue, ChemotestCareplus (M) Sdn Bhd · 2017
  • K152593Latex Examination Glove Powder FreeCareplus (M) Sdn Bhd · 2016

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