Document 5Lnr30xjM16ayrjy8LnXYZrkJ

a/ */o ^ ? October 30, 1989 P. J. Kruszynski CL-OTM-3 SUBJECT: GEONS 87501 NAT 021. 87522 NAT 022 AND 87534-TR 001 - FDA STATUS Geons 87501 Nat 021, 87522 Nat 022 and 87534 Tr 001 are composed of ingredients that meet the current requirements for use in contact with foods of type I, II, III, IV (except liquid milk), V, VI, VII, VIII and IX under use conditions D, E, F and G as described in Tables 1 and 2 of 176.170. The ingredients in the above Geon compounds are either listed on an appropriate regulation in 21CFR parts 174 through 186, or are generally recognized as safe (GRAS), or prior sanctioned for such use. The final food contact article must meet the extractive limitations imposed by 21CFR 178.3790. Although it may be suitable, clearance of a material for food contact applications does not necessarily confer acceptance for use in medical applications. In general, there are no regulations which prescribe the composition of medical devices or packaging. Each medical application is evaluated on an individual basis. W. C. Bachtel 91030-2/jp BFG19014 22137001 BFGoodrich 3925 Embatay Pity Akron. OH 44313-1799 PAX 216-374-2333 1st Ploor 216-374-2238 2nd Ploor 216-374-3338 3rd Ploor 216-374-3456 Lagal DATE: October 30, 1989 TO; P. J. Kruszynski PHONE: NUMBER OP PAGES 2 (INCLUDING COVER PAGS) COMMENTS: 2213700: W. C Bachtel phonr:216/374-3422 BFG19015 *0 KOUTE TO: BATH COMPUTER ROOM GEON v i N'il. i cChiMiCHL DOCUMENT # -a-- LMd ."K.~r Hr r'L. j. L-ri i .;. _<:\' j ^ . A 0^-L.^ i-24G6o C' u w V 4 ^-' i . o60o;' 1.660&? . *-r *: y 12 923 SHO 943 / i ->*2-j:; / j. V-H- y-c; 7 x US'Oc v0L034 00L032 !. i_tiYi.`C^ - o6 ! YHrtN i . o4 ULTRAr FLEX n " CA Sl'cARATE-FU5ED e, I'h BiS S i EAR AN IDE i. i. 0 .jlO j_,j 3i0 520 102.J6QQQ TOT AL TYPE SAMPLE! MATCHED TOISSUEO! MARKETINO APPROVALi POUO jRADE CLEANUP REQUIRED #*# ., 049 a . 21 J 3 , 097 Goa 9 i . 619 i o 'j. 0 0 0 4sfc$2>/7l*??0 22137003 BFG19016 ROUTE TO: # BATH COMPUTER ROOM * OfcUN v .l m r l- w ^ ^ 4-ji-#-#*-fr-rt-#-S--rt*-fr #-#-rt-p> -a* #{*-&*-ft- -w-v^> : cu nr-! i lhl GuL-uriEN 7: K 1 (J .ji 2 O 0 G E 0 N V I N T 1_ i\* r'fc i0/50/ :j:;1:-,"i :-;:;'",J- L NATURAL 022 ,`-5! 1 i / _. r\ |_, :vr>r\; i. 22- j. 1_h b f\H- i SH2t.iJ '-`I'-i HPPl. 1 CM I lUi-jS l> 1j 2 2 0 -lL- ' Gc..* 2 C. L. 2 ftl ..'ir r r'AR ! 3- i Ni.'REUiEN ! s o2,y43/9 h-, y/oo2 4 , 14 ~71 9 * 1-i1974 1.99065 .24383 961 941 v 42 9i2 925 943 943 943 ij (j 0 0 11 OOKOuG 7 t i.u~* 7 i O-r: '0 709335 UOL034 OOlOi6 00eU22 nutr r--0 PHHLCl I U K- 1. 2U 1 '4 ti-truiti .:..- NARK i r-'O'-f SUPER _PP i_E X 200 ca si eara i t--fused riINERAL OIL VSF STEARIC ACID--FDA .-E0 luC percent i i0 210 *- 20 -i 1 O 4 i0 510 520 330 i2 SO,S 7o *4 '-; Zi12 4, u-+-t . 390 6. 066 x . 092 1,941 . 243 i02,56000 TOTAL 100.000 TYPE SAMPLE: MATCHED TO: ISSUED: MARKETING APPROVAL: **#* FOOD GRADE CLEANUP REQUIRED **** /ft -C&fcjfC/ "t/2r--' too Lg\ZZ BFG19017 ROUTE * 0; BATH COMPUTER ROOM * -;(#-* -i-r^vir & -* -ft- ** # *jfr * ^ *fr uEGN ViiM ri_ t Dvniviwni. Duu-uMeN f & % it- ^ 4t-ip-l--l---p ** -jJ-vr ft-1> w*- -tt* -a* *$* ***> it # -r- -jj* <}* ^w--Jt*-->" > v "K- nr -fc Hr ?: i? <---- L* C U !'! ;U; -Zfij - ; r - - 4 r-a?r\; 1 -e-L- ,k rttir U OlM i xO;,:. y-jo yyi<5 ""-ri f A vr , , _ . : ( L.!CLt : c. rL.riU i'Vy Li'irn r;K i 2 2 i'M15RED X EN 6EQ uGC r cruCEN 1 '.;> y . / J. -2 -Z O 7. x 7 707 j.. /9hZ6 . 0o697 a 02/>y x .44636 r .xo^.57 .04485 j. 02 040UO y y- i P' -i- 1 vh2 Pa 2 921 76i 946 943 943 y y y h- / - /V/y'LO 7 i 06 *+9 7Ohy3 006276 uoO x i. X 00L02i >XL02 7 00L040 X. A X r 6 r'rin.hU;-! A. U E l'5:TU PaRhl.u x D H 1 A 7 2 2 MARK x?84 vIGuEV dux2 iRS-12) a Xi i o / UOO 4302 3 7ER x C ACID u8p 0R POLYETHYLENE AC629A ARx 3iuWAX 165 PWD 7Wy~ *7 ' /*> <Hr X i. 0 x 6 220 3a o 410 -+2C 5x0 520 530 TOTAL 67- :/20 y-E 3 / , 064 j. m / JO - 009 . 026 . 440 i 62 . 044 100.000 1"7P E 3AMF'LEs i'lA iLi-iD mj- ISSUED! MARKET INO APPROVALa *#** POOD GRADE CLcAiMUP REQUIRED ***# 5^*5 fc? "00 l(OK 37S- fP-0 ifkf **A>*+oUL > ULhulmj bxM. ^ C0 L1J R J&t -4$*y0 22137005 BFG19018