(2) The quantity of the color additive does not exceed 2 percent by weight of the suture material. The filaments are cooled, oriented by drawing, and set by annealing. The mixture is heated to a temperature of 500-550 deg.F. (1) For coloring procedure, the color additive is blended with the polyethylene resin. The color additive chromium-cobalt-aluminum oxide may be safely used for coloring linear polyethylene surgical sutures, United States Pharmacopeia (U.S.P.), for use in general surgery, subject to the following restrictions: Lead and arsenic shall be determined in the solution obtained by boiling 10 grams of the chromium-cobalt-aluminum oxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid. Total oxides of aluminum, chromium, and cobalt not less than 97 percent. Lead (as Pb), not more than 30 parts per million.Īrsenic (as As), not more than 3 parts per million. Chromium-cobalt-aluminum oxide shall conform to the following specifications:Ĭhromium, calculated as Cr2 O3, 34-37 percent.Ĭobalt, calculated as CoO, 29-34 percent.Īluminum, calculated as AL2 O3, 29-35 percent. It may contain small amounts (less than 1 percent each) of oxides of barium, boron, silicon, and nickel. The color additive chromium-cobalt-aluminum oxide is a blue-green pigment obtained by calcining a mixture of chromium oxide, cobalt carbonate, and aluminum oxide. PART 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION The information on this page is current as of Jan 17, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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