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Fda 20210310

This test report summarizes results for silicone sample GA-1053 submitted by Shenzhen Genvan Silicone Materials Co., Ltd. and Dongguan Genvan Silicone Technology Co., Ltd. Testing was conducted from March 4th to 10th, 2021 according to FDA 21 CFR 177.2600 for total extractive residues. All results met the permissible limits and the sample passed testing. The report provides test method details, results for distilled water, n-hexane and subsequent extractions, as well as photos and remarks.

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475 views

Fda 20210310

This test report summarizes results for silicone sample GA-1053 submitted by Shenzhen Genvan Silicone Materials Co., Ltd. and Dongguan Genvan Silicone Technology Co., Ltd. Testing was conducted from March 4th to 10th, 2021 according to FDA 21 CFR 177.2600 for total extractive residues. All results met the permissible limits and the sample passed testing. The report provides test method details, results for distilled water, n-hexane and subsequent extractions, as well as photos and remarks.

Uploaded by

Dana
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Test Report. No. CANML2103046101 Date: 10 Mar 2021 . Page 1 of 4.

SHENZHEN GENVAN SILICONE MATERIALS CO., LTD .


DONGGUAN GENVAN SILICONE TECHNOLOGY CO., LTD
NO.29 SHAKENG ROAD,BILING,PINGSHA,SHENZHEN CHINA
B3 BUILDING,2ND DISTRICT,XICHENG INDUSTRIAL ZONE HENGLI TOWN,DONGGUAN,CHINA
.

.
The following sample(s) was/were submitted and identified on behalf of the clients as : GA-1053 .

SGS Job No. : GZIN2103010413PC - GZ .


Tested Sample Info. : . GA-1053.
Client Ref. Info. : . Please See Remark .
Date of Sample Received : . 04 Mar 2021.
Testing Period : . 04 Mar 2021 - 10 Mar 2021 .
Test Requested : . Selected test(s) as requested by client. .
Test Method : . Please refer to next page(s). .
Test Results :. Please refer to next page(s). .

Result Summary : .
Test Requested. Conclusion.
FDA 21 CFR 177.2600–Total extractive residues .. PASS.

Signed for and on behalf of


SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch.

Ivy Ren.
Approved Signatory . . .
Test Report. No. CANML2103046101 Date: 10 Mar 2021 . Page 2 of 4.

Test Results :.

Test Part Description : .

Specimen No.. SGS Sample ID. Description. Material


(claimed by the client).
SN1. CAN21-030461.001 Transparent silicone sheet . Silicone.

FDA 21 CFR 177.2600–Total extractive residues.

Test Method : . With reference to US FDA 21 CFR 177.2600. .

Simulant Used. Time. Temperature. Max. Permissible Result of 001 Comment.


Limit.
Distilled Water .. 7.0hr(s).. Reflux 20mg/inch². <0.5mg/inch² .. PASS..
temperature..
Succeeding Extraction .. 2.0hr(s).. Reflux 1mg/inch². <0.5mg/inch² .. PASS..
temperature..
n-Hexane.. 7.0hr(s).. Reflux 175mg/inch². 9.8mg/inch².. PASS..
temperature..
Succeeding Extraction .. 2.0hr(s).. Reflux 4mg/inch². <0.5mg/inch² .. PASS..
temperature..

Notes :.
mg/inch²= milligram per square inch .
Test Report. No. CANML2103046101 Date: 10 Mar 2021 . Page 3 of 4.

Remark：

GA-10 series/GA -11 series/GA-12 series/GA-13 series/GA -14 series/GA-15 series/

GA-16 series/GA -17 series/GA-18 series/GA-19 series/ GA20 series/ GA21 series/

GA22 series/ GA23 series/ GA24 series/ GA2 5 series/GA26 series / GA27 series/

GA28 series/ GA29 series/GA -30 series/GA-31 series/GA -32 series/GA-33 series/

GA-34 series/GA -35 series/GA-36 series/GA-37 series/GA -38 series/GA-39 series/

GA-51 series/GA -52 series/GA-53 series/GA-54 series/GA -55 series/GA-56 series/

GA-57 series/GA -58 series/GA-59 series/GA-60 series /GA -61 series /GA-62 series /

GA-63 series /GA -64 series /GA-65 series /GA-66 series /GA -67 series /GA-68 series /

GA-69 series /GA -70 series/GA-71 series/GA-72 series/GA -73 series/GA-74 series/

GA-75 series/GA -76 series/GA-77 series/GA-78 series/GA -79 series/ GA-80 series/

GA-81 series/ GA -82 series/ GA-83 series/ GA-84 series/ GA -85 series/ GA-86 series/

GA-87 series/ GA -88 series/ GA-89 series/GA-90 series /GA -91 series /GA-92 series /

GA-94 series /GA-95 series /GA-96 series /GA-97 series /GA -98 series /GA-99 series
Test Report. No. CANML2103046101 Date: 10 Mar 2021 . Page 4 of 4.

Sample photo: .

CANML2103046101

CAN21-030461.001 .

SGS authenticate the photo on original report only .

*** End of Report *** .

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