FDA O-Rings and Seals
The FDA, or Food and Drug Administration, is
responsible for granting approval to products used in the equipment for the
processing or storage of food and...
read
more Rubber components used in medical
equipment and devices for surgical application may come into direct contact
with human tissue, and bio-compatibility...
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more
Food
Contact Materials are used extensively on a daily basis as in the form of
kitchenware, packaging materials and equipment, food appliances...
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more
No. 15, Kung Yeh East 4th Rd., Lukang
Chang Hua 505, Taiwan, R.O.C.
Tel: +886-4-7810288
https://www.fdao-ring.com/
email ask@gmors.com
CFR 21 FDA 177.2600
USP Class VI <88> (in vivo)
European Framework Regulation EC 1935/2004
FDA O-Rings, USP Class 6 O-Rings, EC 1935/2004 O-Ring
Gmors is a
manufacturer of rubber components that is in compliant with USP Class VI
<88>, FDA 21 CFR 177.2600 and European Framework Regulation EC
1935/2004 standards. Our products include o-rings, seals and gaskets in
both standard and non-standard sizes as well as custom molded rubber seals.
Material choice include Silicone, Viton and EPDM. Our product range also
include NSF-61 and WRAS certified drinking water o-rings and seals for
potable water sealing applications.
Food and Drug, Medical and Pharmaceutical Application of O-Rings and
Seals
Gmors rubber products are sold worldwide to leading medical devices and
equipment manufacturers, as well as manufacturers of food processing
equipment, pharmaceutical and drugs and other related equipment in the
healthcare industries. Our products are commonly found in medical pumps and
cylinders, fluid transfer equipment, drug delivery tubing, respiratory
devices, sanitary pumps, sanitary diaphragm valves, medical filtration units
and more.
At Gmors, we offer elastomeric sealing products that have undergone
stringent bio-compatibility and low toxicity testings. Elastomer types
include bisphenol cured FKM and peroxide cured EPDM.
Contact us today for technical consultation and a price quotation.
| Approval | Tested by | Specification | Compound Reference | Elastomer Compound | Shore Hardness | Color |
| FDA 21 CFR | Internal approval | ¡± 177.2600 | ¡@ | NBR | From Shore A 60~90 | Customized |
| FDA 21 CFR | Internal approval | ¡± 177.2600 | ¡@ | EPDM | From Shore A 60~90 | Customized |
| FDA 21 CFR | Internal approval | ¡± 177.2600 | ¡@ | VMQ | From Shore A 60~90 | Customized |
| FDA 21 CFR | Internal approval | ¡± 177.2600 | ¡@ | FKM | From Shore A 60~90 | Customized |
| EC 1935/2004 | SGS Taiwan | ResAP(2004)4 | E7083AA | EPDM perox. | 70 ¡Ó5 Shore A | Black |
| EC 1935/2004 | SGS Taiwan | ResAP(2004)4 | N7041AA | NBR sulf. | 70 ¡Ó5 Shore A | Black |
| EC 1935/2004 | SGS Taiwan | ResAP(2004)4 | V7502AA | FKM bisphenol | 75 ¡Ó5 Shore A | Black |
| USP Class VI ¡V 121 ¢XC | Eurofins | Chapter 88 (in vivo) | V7092AP | FKM bisphenol | 70 ¡Ó5 Shore A | White |
| USP Class VI ¡V 121 ¢XC | Eurofins | Chapter 88 (in vivo) | E7003AP | EPDM perox. | 70 ¡Ó5 Shore A | White |
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