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Medical Silicone Gel Sheet
Technical requirement number of medical device: Guangdong FDA 20172140227

Registration number of product:
Guangdong FDA 20172140227

Production license number: Guangdong FDA 20010347
Indication:
Apply to the scar on the human body surface for the auxiliary treatment of scar protection.
  Product Details
Strong adhesive properties
Approved by CFDA
Multiple profiles and sizes
The water vapor permeance is more than 30g/(m2×24h)


Medical Silicone Gel Sheet
Method of use:
The product shall be used after wound healing or taking out stitches. Before use:
1)Firstly, clean the scar area;
2)Then carefully remove the isolation film in the back of the sheet, and apply the sticky side to the scar area.


Type Spec. Length
(mm)		 Width
(mm)		 Thickness
(mm)
Rectangular30?8080±4mm30±2mm1.5±0.5mm
80?120120±5mm80±4mm
30?120120±5mm30±2mm
30?160160±5mm30±2mm
30?200200±5mm30±2mm
50?240240±5mm50±2mm
100?240240±5mm100±2mm
60?120120±5mm60±2mm
120?150150±5mm120±2mm
120?210210±5mm120±5mm
30?150150±5mm30±2mm
25?120120±5mm25±2mm
Cambered35?150150±5mm35±5mm1.5±0.5mm



Type Spec. Outer
Diameter
(mm)		 Inside
Diameter
(mm)		 Thickness
(mm)
CircularR60Φ60±5mmΦ20±2mm1.5±0.5mm
R80Φ80±5mmΦ20±2mm






Contraindications, precautions, warnings and suggestive notes:

1) Do not use in case of unhealed scar, secretion, or inflammation and infection in the wound;

2) Shall be used under the guidance of a doctor;

3) For external use only;

4) Forbidden for allergic constitution;

5) Stop use immediately when any allergy occurs during the application;

6) Can use the thin elastic gauze or tape to fix it while sleeping or doing strenuous exercises;

7) Medical silicone gel sheet can be reused. Keep the sticky side surface clean in use. Avoid the adhesion of too many impurities which may lead to a loss of viscosity; Keep the product structure integrity in use; Avoid a product break by excessive pulling; Wash with warm water when the sheet is dirty and reuse after drying.

8) The inner packing is a PET case. The outer packing is a paper box.

9) Keep it out of reach of children when not in use.



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