510(k) Report

FDA applicant

Pt. Medisafe Technologies

Medan, North Sumatra, ID19 decisions2001–20201 recall

FDA records 19 decisions for Pt. Medisafe Technologies (Medan, North Sumatra, ID) from 2001 to 2020: 19 510(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 153 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. 1 recall is linked to its devices, 1 Class I.

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 Pt. Medisafe Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12010: 12011: 12012: 12014: 12015: 22017: 12018: 12019: 12020: 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1, 1 Class I
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pt. Medisafe Technologies by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pt. Medisafe Technologies’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?

  • LZAPolymer Patient Examination Glove10decisions
  • KGOSurgeon'S Gloves8decisions
  • LYYLatex Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 153 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 159 days; 3 of its 4 were faster than that.

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy DrugsPt. Medisafe Technologies · 20191cites it

What has FDA decided for it lately?

  • K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with…Pt. Medisafe Technologies · 2020
  • K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy DrugsPt. Medisafe Technologies · 2019
  • K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with ChemotherapyPt. Medisafe Technologies · 2018
  • K163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin EPt. Medisafe Technologies · 2017
  • K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs…Pt. Medisafe Technologies · 20151 Class I recall
  • K142190Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene…Pt. Medisafe Technologies · 2015
  • K133689Powder Free Polychloroprene Light Wieght Examinationgloves- Green,Blue and PinkPt. Medisafe Technologies · 2014
  • K112654Powderfree Polyisoprene Surgical GlovesPt. Medisafe Technologies · 2012

All 19 as Pt. Medisafe Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142941Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Feb 27, 2026Class I