Allstar Sdn. Bhd.

Allstar Sdn. Bhd. specializes in producing non-sterile latex examination gloves, which are intended for single-use medical and clinical examinations. These gloves are designed to provide a barrier during procedures like physical assessments, blood pressure checks, or other non-invasive examinations.

Allstar Sdn. Bhd. is based in the United States, which means its devices are regulated under FDA guidelines. Since the company’s products fall under Class I classification (low-risk devices), they are typically listed via the 510(k) pathway, though this does not imply FDA clearance—it simply confirms compliance with applicable regulations for the specific device type.

Allstar Sdn. Bhd.’s devices are listed in the FDA’s 510(k) database, which tracks Class I medical devices that have undergone the required regulatory pathway. This listing confirms that the company’s non-sterile latex examination gloves meet FDA requirements for their intended use, though it does not constitute approval for the company itself.

Allstar Sdn. Bhd.’s non-sterile latex examination gloves are classified as Class I devices under FDA regulations. This classification is based on their low-risk profile for single-use, non-invasive medical examinations, meaning they are subject to general controls (like labeling and manufacturing standards) rather than pre-market approval. The 510(k) pathway is commonly used for such devices to demonstrate compliance.