Pt. Maja Agung Latexindo
US Last updated 23 May 2026
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- Devices
- 11
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Powder Free Nitrile Examination Gloves, Black Ref K161099
Mal Latex Examination Gloves Ref K896604
Powder Free Latex Examination Gloves, Black Ref K062709
Latex Examination Gloves-Pre-Powdered-Sterile Ref K994255
FDA establishments
- 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.
Frequently asked questions
What types of medical devices does Pt. Maja Agung Latexindo manufacture?
Pt. Maja Agung Latexindo manufactures single-use examination gloves, primarily focusing on latex and nitrile varieties. Their product line includes powder-free nitrile gloves, latex gloves (both powder-free and pre-powdered), and surgeon’s gloves. Some gloves are designed for specialized applications like chemotherapy compatibility or resistance to simulated gastric acid, while others feature protein content labeling claims. The portfolio also covers sterile and non-sterile options in multiple sizes and colors.
Where is Pt. Maja Agung Latexindo based?
Pt. Maja Agung Latexindo is based in the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional details are not provided.
Which regulatory registries list Pt. Maja Agung Latexindo’s devices?
Pt. Maja Agung Latexindo’s devices are listed in the FDA’s 510(k) database. This registry tracks Class I medical devices that have undergone the 510(k) premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device.
How are Pt. Maja Agung Latexindo’s gloves classified under FDA regulations?
Pt. Maja Agung Latexindo’s gloves are classified as Class I medical devices under FDA regulations. This classification applies to low-risk devices like single-use examination gloves, which typically require general controls (such as good manufacturing practices) rather than stringent pre-market approval. The 510(k) pathway is used to demonstrate that these devices meet the same performance criteria as existing, legally marketed equivalents.
Information
- Country
- US