# Pt. Medisafe Technologies

- Location (FDA's records): Medan, North Sumatra, ID
- FDA decisions: 19 (2001–2020): 19 510(k) clearances
- Product codes: LZA (10), KGO (8), LYY (1)
- 510(k) review time since 2016: median 153 days, against 159 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ever Growth (Vietnam) Co., Ltd.: 1 (https://510kreport.com/company/ever-growth-vietnam)

## Its most-cited devices
- K182176: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs (2019), cited by 1

## Recent decisions
- K201774: Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs (Sep 16, 2020)
- K182176: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs (Mar 28, 2019)
- K173258: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy (Apr 20, 2018)
- K163041: Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E (Feb 22, 2017)
- K142941: Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. (Nov 2, 2015)
- K142190: Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs (Jul 14, 2015)
- K133689: Powder Free Polychloroprene Light Wieght Examinationgloves- Green,Blue and Pink (Jul 3, 2014)
- K112654: Powderfree Polyisoprene Surgical Gloves (Feb 17, 2012)

Source page: https://510kreport.com/company/pt-medisafe-technologies