Data / Medical devices / Indonesia / PT. Medisafe Technologies
PT. Medisafe Technologies: FDA-registered device maker in Kab. Deli Serdang Sumatera Utara, Indonesia, 26 510(k) clearances
PT. Medisafe Technologies is registered with the FDA (registration 9616501) in Kab. Deli Serdang Sumatera Utara, Indonesia. It lists 6 device types. The FDA files 26 510(k) clearances under its listings, the newest dated August 28, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616501
- FEI number
- 3002955419
- Address
- Jl. Batang Kuis Gg. Tambak Rejo / PSR IX, Desa/Kelurahan Buntu Badimbar, Kec.Tanjung Morawa, Kab. Deli Serdang Sumatera Utara, Indonesia, 20362
- Owner or operator
- PT. MEDISAFE TECHNOLOGIES (9019595)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- Latex Examination Gloves, Latex Examination gloves, Nitrile Examination Gloves, Polychloroprene Powder-Free Surgical Glove Tested For Use With Chemotherapy Drugs-White & Green., Powderfree Polyisoprene Surgical Gloves, Sterile Polychloroprene Examination, Sterile Synthetic Rubber Exam Glove, Synthetic Rubber Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2023 | K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| July 21, 2023 | K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| August 11, 2021 | K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| September 16, 2020 | K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| May 1, 2020 | K200453 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| March 28, 2019 | K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| March 19, 2019 | K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | LZC | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| April 20, 2018 | K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| December 29, 2017 | K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| November 2, 2016 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| November 27, 2015 | K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 2, 2015 | 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. | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| May 30, 2014 | K133123 | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| February 17, 2012 | K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| June 6, 2011 | K102623 | BLUE POWDERFREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| January 13, 2005 | K042567 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| December 1, 2004 | K041913 | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| April 22, 2004 | K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| March 14, 2003 | K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 19, 1999 | K984449 | NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM | LYY | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| November 5, 1998 | K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| September 12, 1997 | K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| December 19, 1996 | K962518 | NITRILE COPOLYMER PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| January 4, 1996 | K953462 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
| November 7, 1991 | K913776 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | P.T. Irama Dinamika Latex | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Latex Patient Examination Glove
Updated August 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.