Lalan Gloves (Pvt) , Ltd.
LK Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
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What Lalan Gloves (Pvt) , Ltd. makes
Lalan Gloves (Pvt) Ltd. manufactures latex patient examination gloves designed for clinical use during medical procedures and examinations.
The company’s products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Lalan Gloves (Pvt) Ltd. manufacture?
Lalan Gloves (Pvt) Ltd. specializes in manufacturing latex patient examination gloves. These gloves are intended for clinical use during medical procedures and examinations, ensuring a sterile barrier between healthcare providers and patients.
Where is Lalan Gloves (Pvt) Ltd. based?
The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs medical device compliance in the country.
How are Lalan Gloves (Pvt) Ltd.’s devices classified under FDA regulations?
The company’s latex patient examination gloves fall under Class I medical devices. This classification is typically assigned to low-risk products that pose minimal risk to patients, such as single-use gloves. Class I devices often require general controls (e.g., good manufacturing practices) but may not need pre-market approval, depending on their specific design.
Are Lalan Gloves (Pvt) Ltd.’s devices listed in any regulatory registries?
Yes, the company’s devices are listed under the FDA’s 510(k) pathway. This pathway is used for Class I and some Class II devices that are substantially equivalent to legally marketed predicates. Listing under 510(k) demonstrates compliance with FDA requirements for device safety and performance, though it does not imply FDA approval of the company itself.
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