PT. Medisafe Technologies
Kab. Deli Serdang Sumatera Utara, ID
PT. MEDISAFE TECHNOLOGIES appears in FDA device records in Kab. Deli Serdang Sumatera Utara, ID. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for PT. Medisafe Technologies between 2001 and 2020. The busiest year on record is 2004, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | KGO | Substantially Equivalent | |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E | LZA | Substantially Equivalent | |
| 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 | |
| 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 | KGO | Substantially Equivalent | |
| K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | LZA | Substantially Equivalent | |
| K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K102623 | BLUE POWDERFREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K102620 | POWDERFREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K082302 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM | LZA | Substantially Equivalent | |
| K050968 | POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K042567 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E | KGO | Substantially Equivalent | |
| K041913 | POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE | LZA | Substantially Equivalent | |
| K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K033086 | NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE | LZA | Substantially Equivalent | |
| K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K010483 | POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0 | LYY | Substantially Equivalent | |
| K010486 | POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616501 | 3002955419 | PT. MEDISAFE TECHNOLOGIES | Jl. Batang Kuis Gg. Tambak Rejo / PSR IX, Desa/Kelurahan Buntu Badimbar, Kec.Tanjung Morawa, Kab. Deli Serdang Sumatera Utara 20362 ID | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain