FDA 510k Silver Ion Nonwoven Fabric Antimicrobial Dressing
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- Model NO.: nw12
- Material: Non-woven Fabric
- Ethylene Oxide Sterilization: Gamma
- Group: Adult
- Trademark: agem
- Specification: 2.5X30cm, 10X10cm, 12.5X12.5cm, 5X5cm
- HS Code: 3005901000
- Type: Surgical Supplies Materials
- Certification: CE, FDA, ISO13485
- Quality Guarantee Period: Two Years
- Logo Printing: With Logo Printing
- Transport Package: Paper-Film Pouch
- Origin: China
Ag Mesh Dressing with Silver is a nonwoven gauze dressing that contains silver sulfate, 8 mg/g of dressing. Silver sulfate released as silver ions within the dressing
creates an effective barrier for up to 7 days. The soft, absorbent dressing is supplied sterile and may be custom cut. The porous, nonocclusive dressing conforms to the wound base
and wicks drainage into the dressing where the silver ions are available to reduce the number of bacteria and yeast that are absorbed into the dressing.
Indications for Use
Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over:
• trauma wounds
• surgical wounds
• first and second degree burns
• donor sites
This product is not designed, sold or intended for use except as indicated.
Ag Mesh Dressing with Silver should not be used on individuals that have a known hypersensitivity to silver or cotton. This product is not indicated for use as a surgical
sponge or for use on third degree burns. This product should not be used with enzymatic debriding agents that are contraindicated for use with silver products.
Federal Law (U.S.A.) restricts the device to sale by or on the order of a licensed health care professional.
1. Ag Mesh Dressing with Silver must be moist to release ionic silver and minimize adherence to the wound. When used on dry or minimally draining wounds, the dressing
should be moistened prior to application.
2. It is possible that the amount of drainage could decrease rapidly during dressing use. Nonwoven material may adhere to the wound or site if allowed to dry; this may result in
disruption of the wound or site upon removal. When using the dressing, the health care professional may want to change the dressing more frequently to maintain moisture of the dressing and observe the condition of the wound or site.
3. If the dressing has dried and is adhered to the wound surface, saturate with sterile normal saline or sterile water, allow the dressing to soften, and gently remove.
4. Consult a health care professional if any signs of infection are noted. Signs of infection may include: pain, redness, swelling, unusual odor or drainage, absent or delayed healing,
or fever. This dressing may be used on infected wounds only under the care of a health care professional.
5. If the wound does not begin to show signs of healing or if any other unexpected symptoms occur, consult a health care professional.
6. For external use only.
7. Remove the dressing prior to MRI (Magnetic Resonance Imaging) procedures.
8. Avoid cutting the dressing into narrow strips; the dressing may be rolled for use in tunneled wounds which helps retain the tensile strength of the dressing.
9. Clinicians/Healthcare Professionals should be aware that there are very limited data on prolonged and repeated use of silver containing dressings, particularly in children
10. Do not reuse. Reuse may result in compromising product integrity and lead to device failure.
Shenzhen Yuanxing Nano-Pharma Co., Ltd. was founded in 2001 and today stands as a national high-tech enterprise and also one of the most professional manufacturers of advanced medical dressing in China. We specialize in R&D, producing and distributing advanced functional medical dressings, silver antimicrobials and biological antimicrobials.
We perform a quality management system complying to ISO13485. Products are obtained CE certification and on the way of applying US FDA approval of Silver Ion antimicrobials.
We have Continually 5 years Evaluated as Guangdong quality & assurance--Grade A medical device manufacturer and got 10 Native patent ,4 PCT protection , over 50 Chinese registered trademark.