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Pt. Maja Agung Latexindo

FDA registration: Indonesia Last updated 23 May 2026

Devices
11
Registries
FDA 510(k)FDA
FDA recalls
0

Catalogue11

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • P.T. Maja Agung Latexindo SUNGGAL DELI SERDANG Sumatera Utara · ID FEI 3000239897

What Pt. Maja Agung Latexindo makes

The company manufactures single-use examination gloves, including powder-free nitrile and latex varieties in multiple sizes and colors, as well as pre-powdered surgeon’s gloves. Some products are designed for chemotherapy compatibility or simulated gastric acid resistance, while others carry protein content labeling claims. Sterile and non-sterile latex gloves are also part of the portfolio, with both pre-powdered and powder-free options.

These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States, and its products are registered in the FDA’s 510(k) database.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Pt. Maja Agung Latexindo have in the registry?

The registry currently lists 11 devices for Pt. Maja Agung Latexindo. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pt. Maja Agung Latexindo's devices?

Among its 11 most recently registered devices, Pt. Maja Agung Latexindo has devices listed in FDA 510(k) (11 devices).

What risk classes do Pt. Maja Agung Latexindo's devices fall under?

Among its 11 most recently registered devices, the classes recorded for Pt. Maja Agung Latexindo's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Pt. Maja Agung Latexindo in the registry?

The most recently registered devices listed for Pt. Maja Agung Latexindo include POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE, Powder Free Nitrile Examination Gloves, Black, LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE and SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5.

Which FDA establishments are linked to Pt. Maja Agung Latexindo?

1 FDA establishment is linked to Pt. Maja Agung Latexindo in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

FDA registration
Indonesia(from the FDA establishment record (FEI))