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SILVALPAD™ MATERIAL SAFETY DATA SHEET Product name: Silver Alginate Antimicrobial Dressing Ref nos. of sets containing Silvalpad: 00923/16, 00923/17, 00923/18, 01143, 01144, 01145, 01146, 01147. Product and Company Identification Product name: Silvalpad™, Intended Use: Antimicrobial dressing, for effective treatment of wounds, burns & catheter and orthopedic pins exit sites Other companies supplying similar product under the following names: B. Braun Hospicare – Askina® Biomedical Technologies Inc - Calgitrol®Argentum Medical - Silverlon®Smith and Nephew - Acticoat -Johnson and JohnsonActisorb® Silver 220 -Johnson and Johnson - Silvercel® Coloplast - Contreet® Foam -DeRoyal – Algidex™ Ag. CENTORION® Healthcare Products – SilverSite™ Supplier: Manufacturer:
Pollak (International) Ltd Tel: 972 3 9022885 Fax: 972 3 9024531 Web: www.euroband.com email: pollak@euroband.com Indications Silvalpad™ wound dressing is recommended dressing for the management of infected or non infected wounds, burns, orthopedic exit site pins and the exit site of a chronic catheter. Composition/Information on Ingredients: (5 options available) OPTION I: PLAIN Silver coated nylon threads forming a woven or knitted fabric. (20% silver of weight) OPTION II: FOAM BACKING
I. Propylene Glycol
: Wt. %: < 1 OPTION III: VISCOSE (RAYON) BACKING I. Silver coated nylon threads forming a woven or knitted fabric (20% silver of layer weight). II. Highly absorbent pure Viscose (Rayon) III. Water-repellent layer. OPTION IV: VISCOSE (RAYON) BACKING I. Silver coated nylon threads forming a woven or knitted fabric (20% silver of layer weight). II. Highly absorbent pure Viscose (Rayon) OPTION V: VISCOSE (RAYON) BACKING I. Silver coated nylon net (1.2% average silver of layer weight). II. Highly absorbent pure Viscose (Rayon) III. Water-repellent layer. Properties: Silvalpad™ has been formulated with a combination of ionic silver and alginate to provide broad antimicrobial effectiveness and help contamination from external bacteria. Hazards Identification: Emergency Overview: No Hazards to Incidental or Prolonged Exposures When visible signs of infection are present in the wound, Silvalpad™ may only be used when proper systemic medical treatment addresses the cause of the infection.
Contraindication:
Silvalpad™ is for external use only. Do not use if pack is damaged or open. Signs and Symptoms of Overexposure
(Primary Route of entry: Skin) Ingestion: N.A. Inhalation: N.A.
Effects of Chronic Exposure: None Known First Aid Measures Eyes: N.A. Skin: N.A.
Ingestion:
N.A. Fire Fighting Measures Flash point and Method: N.A. Flammable Limits: Method: N.A. Autoignition temperature: N.A. Extinguishing media: Water, carbon dioxide, dry chemical, or halogen foam. Special Fire Fighting Procedures: Fire fighters should wear a self-contained breathing apparatus. Hazardous combustion Products: Decomposition by-products may include carbon monoxide, carbon dioxide, and oxides of nitrogen. Accidental Release Measures: Material is sponge solid no spillage measures are required Handling and Storage:
Handling precautions: None Exposure Control/Personal Protection Engineering Controls: General exhaust is adequate Eyes: None necessary under normal conditions of use. Respirator: None necessary under normal conditions of use.
Skin: None necessary under normal
conditions of use. Work/Hygienic Practices: Practice good personal hygiene. Physical and Chemical Properties Appearance: Purplish gray to brown paste form, a thin sheet or coated on foam substrate Vapor Pressure: N.A.
Solubility in Water:
N.A. Boiling Point: N.A. Odor: No discernable odor Vapor Density: N.A.
Specific Gravity:
N.E. Stability and Reactivity General: Stable
Incompatible Materials:
Strong Oxidizing Agents Toxicological Information:
Carcinogenicity: NTP: no OSHA: no
LD50:
N.E. Ecological Information: NE Disposal Considerations: Dispose or incinerate in accordance with all applicable regulations for disposed medical products. Transportation Information: No specific requirements to be met; not regulated as a hazardous material. Regulatory Information: USA – FDA – 510K # K041268 for CALGITROL™ Ag Silver Alginate Foam. USA - FDA - 510(k) # K981 299 for for Silverlon® products. For CE, look at: http://www.euroband.com/ISOCE.pdf Other Information: Legends: NA= not applicable NE = Not Established ND = Not Determined Approved by: POLLAK (INTERNATIONAL) LTD – Quality Assurance Approval Date : March 2nd 2006
Note: The information
on this MSDS is based on data considered to be accurate on the date of
preparation of this document. However, no warranty or representation,
express or implied, is made as to the accuracy or completeness of the
data and safety information. This MSDS represents our current data and
best opinion as to the proper use in handling of this product under the
normal conditions of its use. Any use of this product which is not in
conformance with the data sheet or product labeling, or which involves
the product in combination with any other material or processes or
interactions is the responsibility of the user.
This information
should not be construed as a legal contract or guaranteeing any specific
property of the product. |
