Data / Medical devices / Indonesia / P.T. Maja Agung Latexindo
P.T. Maja Agung Latexindo: FDA-registered device maker in SUNGGAL DELI SERDANG Sumatera Utara, Indonesia, 7 510(k) clearances
P.T. Maja Agung Latexindo is registered with the FDA (registration 8041150) in SUNGGAL DELI SERDANG Sumatera Utara, Indonesia. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8041150
- FEI number
- 3000239897
- Address
- Jl.utama No.98 Puji Mulio, SUNGGAL DELI SERDANG Sumatera Utara, Indonesia, 20352
- Owner or operator
- P.T. MAJA AGUNG LATEXINDO (8041150)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- Polysilk, Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl), Private brands, Shamrock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | 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 |
|---|---|---|---|---|---|---|
| May 18, 2022 | K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | LZA | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| February 23, 2017 | K161099 | Powder Free Nitrile Examination Gloves, Black | LZA | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| August 28, 2008 | K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| December 6, 2006 | K062709 | POWDER FREE LATEX EXAMINATION GLOVES, BLACK | LYY | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| February 26, 2002 | K013996 | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE | LYY | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| June 23, 2000 | K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
| December 23, 1998 | K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Pt. Maja Agung Latexindo | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
Updated May 18, 2022. 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.