B J L Glove (M) Sdn. Bhd.
Malaysia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Prolife Patient Examination Gloves (Latex) Ref K891660
What B J L Glove (M) Sdn. Bhd. makes
B J L Glove (M) Sdn. Bhd. manufactures latex patient examination gloves designed for clinical use, ensuring sterile protection during medical procedures.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does B J L Glove (M) Sdn. Bhd. manufacture?
B J L Glove (M) Sdn. Bhd. specializes in manufacturing latex patient examination gloves, specifically designed for clinical and medical use. These gloves provide sterile protection during procedures, ensuring hygiene and safety for both patients and healthcare providers.
Where is B J L Glove (M) Sdn. Bhd. based?
The company is headquartered in the United States, where it operates its manufacturing and distribution operations.
How are the company’s devices classified under FDA regulations?
The company’s latex patient examination gloves are classified as Class I devices under FDA regulations. This classification applies to products posing minimal risk, where general controls are sufficient to ensure safety and effectiveness.
Are B J L Glove (M) Sdn. Bhd.’s devices listed in any regulatory registries?
Yes, the company’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class I devices that are substantially equivalent to legally marketed predicates, ensuring compliance with FDA requirements.
Information
- Country
- Malaysia