Major Milestone | Our High-End Collagen Dressing Earns FDA 510(k) Clearance !

Release time:

2026-06-09

Exciting news for advanced wound care! Roosin Medical Co., Ltd. has officially received FDA 510(k) clearance for its premium type I bovine Collagen Dressing.

Roosin Medical Co., Ltd., a dedicated manufacturer of high-end medical dressings, is proud to announce that our advanced Collagen Dressing has officially received FDA 510(k) clearance. This major regulatory milestone highlights our ongoing commitment to delivering safe, effective, and innovative solutions to the global healthcare market.

Our FDA-cleared Collagen Dressing is engineered to optimize the healing environment for a wide variety of complex injuries. It is a gentle, hydrophilic dressing composed entirely of fibrous type I bovine collagen. Designed specifically as a sterile, disposable, single-use wound dressing, it ensures maximum patient safety and clinical hygiene.

To accommodate diverse clinical settings and practitioner preferences, Roosin Medical provides this medical device in both hydrated and dry forms. Furthermore, our standard product specifications can be fully customized to meet the unique technical and sizing requirements of different healthcare institutions.

This versatile medical device is highly effective for the clinical management of multiple wound types. Specifically, the device is indicated to be used for the treatment and management of burns, sores, blisters, ulcers, and other acute or chronic wounds.

Integrating the dressing into a standard patient care routine is straightforward and highly efficient. Healthcare professionals simply need to begin the process by thoroughly cleansing the wound bed. If clinically indicated by the medical situation, the appropriate medication should then be applied directly to the wound.

Following initial preparation, the Collagen Dressing is carefully applied over the wound site. After covering it securely with a proper secondary dressing, the clinical team should continue to use the product consistently until the wound is fully healed.

To fit various wound shapes and sizes perfectly, Roosin Medical offers this cleared dressing in both sheet and powder formats. Available sheet options include sizes such as 5×5cm, 10×10cm, 10×2cm, 15×15cm, and 20×40cm. The powder options are supplied in precise quantities ranging from 0.5g up to 5g per unit.

With this newly acquired clearance, Roosin Medical Co., Ltd. is fully prepared to scale up manufacturing and supply to hospitals, clinics, and medical distributors worldwide. Contact our team today to request product samples or discuss international distribution opportunities!

Better Roosin Better Life！

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