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Sterile oral inspection kit
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【Product name】 Sterile oral inspection kit
[Specifications] Type I, Type II
[License Number] Yu Food and Drug Administration Apparatus Production Xu 20150036
[Registration Certificate Number] Yu Weapon Note 20152660751
【Registration product standard】YZB/Yu 0485-2014
[Product performance structure and composition] Type I consists of basic configuration of mouth mirror, disposable treatment towels and optional configuration of disposable tweezers, dental probes, disposable film examination gloves, toilet paper, aprons, medical cotton balls, medical cotton swabs, disposable Sexual use medical rubber examination gloves, trays, medical degreased gauze laminates, disposable tongue depressors, disposable medical wrapping sets
 Into; Type II consists of the basic configuration of disposable treatment towels and optional configuration of disposable tweezers, dental probes, disposable film examination gloves, toilet paper, aprons, medical cotton balls, medical cotton swabs, disposable medical rubber examination gloves, trays , Mouth mirror, medical degreased gauze laminate, disposable tongue depressor, and disposable medical wrapping cloth.
【Main Performance Index】
 1. The components of this product should be clean, free of rust spots, the mouth mirror should be bright, the scarf should be hot pressed flat, uniform, and no seams; the sewing should be straight, the stitch size should be even, each 10cm stitch size is 14-18 stitches.
 2. The surface of the plastic parts of the mouth mirror should be clean, pollution-free, odor-free, burr-free and flash-free. The oral lens should be flat and clean, the image should be clear, and not deformed; the oral lens handle should be able to withstand a static tension of 9.8N for 10s, and the handle should not be broken; the oral lens should be firmly bonded.
 3. The square meter weight of the disposable treatment towel should not be less than 18g/m2
; Its breaking strength: transverse ≥14N, longitudinal ≥20N.
 4. Disposable tweezers should be qualified products with medical device registration certificate.
 5. The dental probe should be a qualified product with a medical device registration certificate.
 6. The disposable film examination gloves should be qualified products with a medical device registration certificate.
 7. The color of toilet paper in the same package should be basically the same; the saturated water absorption of toilet paper should be no less than 6 times the weight of toilet paper before water absorption.
 8. The apron is not less than 18g/m2
Made of toilet paper or non-woven fabric.
 9. The medical cotton ball should be a qualified product with a medical device registration certificate.
 10. The medical cotton swab should be a qualified product with a medical device registration certificate.
 11. The disposable medical rubber examination gloves should be qualified products with a medical device registration certificate.
 12. The tray should be free of water leakage.
 13. The laminated medical degreased gauze should be a qualified product with a medical device registration certificate.
 14. The disposable tongue depressor should be a qualified product with a medical device registration certificate.
 15. The square meter weight of disposable medical wrapping cloth should not be less than 18g/m2
; Its breaking strength: transverse ≥14N, longitudinal ≥20N.
 16. The oral inspection kit should be sterile.
 17. After the oral inspection kit is sterilized by ethylene oxide, the residual amount of ethylene oxide should not exceed 10ug/g.
【 Instructions】
 1. Open the package and check whether the contents of the package are intact.
 2. Use in accordance with clinical operating procedures.
【Notes and warnings】
 1. Please check the packaging before use. Small packages are not allowed to be used if damaged.
 2. This product is sterilized by ethylene oxide and is aseptic and valid for two years.
 3. This product is for one-time use and is destroyed after use.
[Production date, expiration date or expiration date] See packaging.
[Scope of application] Clinically used for oral inspection.
[Contraindications] People who are allergic to the material of this product should not be used.
[Storage conditions] This product should be stored in a relative humidity below 80%, no harmful gas, in a cool, well-ventilated and clean environment.
[Use period] This product is valid for two years from the date of sterilization. Please use it before the expiration date shown on the package or within the use period.


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