Ampri Rubberware Industries Sdn Bhd
MY Last updated 22 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 8
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Ampri Ref K954002
Absogel Sterile Powder-Free Surgical Gloves Ref K945948
Correct Touch Surgeons Gloves Ref K892176
Correct Touch Examination Gloves (Latex) Ref K892175
Absogel Chemotheraphy Gloves Ref K990677
Ampri Ref K952833
What Ampri Rubberware Industries Sdn Bhd makes
The company manufactures powder-free examination and surgical gloves, including non-sterile and sterile latex gloves for general use, chemotherapy applications, and surgeons. Products also include latex examination gloves with a protein labeling claim and powder-free surgeon’s gloves. All listed items are designed for medical and healthcare settings to provide barrier protection during procedures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States, and the portfolio is regulated under the FDA’s medical device authorization framework.
Frequently asked questions
What types of medical devices does Ampri Rubberware Industries Sdn Bhd manufacture?
Ampri Rubberware Industries Sdn Bhd specializes in manufacturing powder-free medical gloves for healthcare settings. Their portfolio includes non-sterile and sterile latex examination gloves, surgical gloves for general and chemotherapy use, and surgeon’s gloves. These products are designed to provide barrier protection during medical procedures, ensuring compliance with medical and healthcare standards.
Where is Ampri Rubberware Industries Sdn Bhd based?
The company is based in the United States. This location places its devices under the regulatory oversight of the FDA, which governs their design, manufacturing, and distribution to ensure safety and performance in medical applications.
Which regulatory registries or databases list Ampri Rubberware Industries Sdn Bhd’s devices?
Ampri Rubberware Industries Sdn Bhd’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class I medical devices, which are generally considered low-risk but still subject to regulatory review to confirm compliance with applicable requirements.
How are Ampri Rubberware Industries Sdn Bhd’s devices classified under FDA regulations?
All of Ampri Rubberware Industries Sdn Bhd’s listed devices fall under Class I classification in the FDA’s regulatory framework. Class I devices are typically low-risk and pose minimal potential harm to users, but they still require adherence to good manufacturing practices (GMP) and other regulatory standards to ensure safety and effectiveness.
Information
- Country
- MY