The Safety of Biolife's Proprietary Powder
Biolife's Powder is a topical hemostatic powder that stops bleeding and absorbs exudate from external wounds
and procedures. The ingredients are a mixture of a hydrophilic polymer and potassium ferrate.
The Toxicology Project Director of STS Duotek, an independent, FDA registered laboratory that routinely
performs Good Laboratory Practice (G.L.P.) studies for the pharmaceutical and medical device industries,
has confirmed and attested to the safety of the Powder.
The following table lists all the studies required by the FDA for mucosal membranes and breached or
compromised surfaces with prolonged contact, the negative control material used, the positive control test
results, and the test result/conclusion.
In each test, the level of toxicity (induced biological reactivity) observed and measured using the powder, Powder was
the same as, and/or statistically equivalent to that caused by the negative control material. In each case, the
positive control elicited a toxicologically significant biological response in the subject animals.
1 FDA Registration # 1316257
2 Reference: FDA Blue Book Memorandum #G95-1, Attachment A; FDA. Modified ISO Testing Matrix: Initial Evaluation Tests; Surface
Devices-Mucosal Membrane & Breached or Compromised Surfaces, Prolonged Exposure. Genotoxicity evaluation was not performed,
FDA regulations only call for that test to be performed for permanently implanted surface devices.
3 STS Duotek used both animals/varieties and control materials as defined in the International Organization for Standardization (ISO),
Biological Evaluation of Medical Devices - Part 6 and/or United States Pharmacopoeia, and performed in compliance with FDA Good
Laboratory Practice regulations (GLP). Caging and care of animals was in compliance with the Animal Welfare Act USDA (1990 and all
subsequent revisions).
4 Data and reports from STS Duotek on file.
Biolife's Powder is a topical hemostatic powder that stops bleeding and absorbs exudate from external wounds
and procedures. The ingredients are a mixture of a hydrophilic polymer and potassium ferrate.
The Toxicology Project Director of STS Duotek, an independent, FDA registered laboratory that routinely
performs Good Laboratory Practice (G.L.P.) studies for the pharmaceutical and medical device industries,
has confirmed and attested to the safety of the Powder.
The following table lists all the studies required by the FDA for mucosal membranes and breached or
compromised surfaces with prolonged contact, the negative control material used, the positive control test
results, and the test result/conclusion.
In each test, the level of toxicity (induced biological reactivity) observed and measured using the powder, Powder was
the same as, and/or statistically equivalent to that caused by the negative control material. In each case, the
positive control elicited a toxicologically significant biological response in the subject animals.
1 FDA Registration # 1316257
2 Reference: FDA Blue Book Memorandum #G95-1, Attachment A; FDA. Modified ISO Testing Matrix: Initial Evaluation Tests; Surface
Devices-Mucosal Membrane & Breached or Compromised Surfaces, Prolonged Exposure. Genotoxicity evaluation was not performed,
FDA regulations only call for that test to be performed for permanently implanted surface devices.
3 STS Duotek used both animals/varieties and control materials as defined in the International Organization for Standardization (ISO),
Biological Evaluation of Medical Devices - Part 6 and/or United States Pharmacopoeia, and performed in compliance with FDA Good
Laboratory Practice regulations (GLP). Caging and care of animals was in compliance with the Animal Welfare Act USDA (1990 and all
subsequent revisions).
4 Data and reports from STS Duotek on file.
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