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Nitrile Glove - The World's Largest Manufacturer of Gloves. NITRILE EXAMINATION GLOVE. Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America ...

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510(k) Number (if known) 1<141982 Device Name Form Approved: OMB No. 0910-0120 Expiration Date: January 31.2017 See PRA Statement on fast page. Dermagrip Powder Free Bluc Nitrile Patient Examination Gloves, Non-Steríle, Tested for use with Chemotherapy Drugs Indications for …

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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue) physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards. 7.0 8.0

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Jun 09, 2021·Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent …

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Traditional 510(k) Premarket Notification Powder Free Nitrile Examination Gloves (Blue) physical characteristics, design, product features, and intended use. Both gloves are made with nitrile latex and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards. 7.0 8.0

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2 天前·polymer patient examination glove: 510(k) Number: K163126: Device Name: Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue) Applicant: Blue Sail Medical Co., Ltd: No. 21 Qingtian Road: Qilu Chemical Industrial Park: zibo, CN 255414 Applicant Contact ...

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K181130 Device Name Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs Indications for Use (Describe) The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a ...

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510(k) Number (if known) 1<141982 Device Name Form Approved: OMB No. 0910-0120 Expiration Date: January 31.2017 See PRA Statement on fast page. Dermagrip Powder Free Bluc Nitrile Patient Examination Gloves, Non-Steríle, Tested for use with Chemotherapy Drugs Indications for …

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Jun 09, 2021·Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent …

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the glove in place. The remainder of the glove should hang freely from the mandrel when filled with water. 3. Pour a minimum of 1000 cm3 of water having a room temperature of 15 to 30°C into the top of the mandrel. The water shall pass freely into the glove. 4. Visually inspect the glove for immediate water leakage. Let the glove

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Nitrile Examination Glove, Blue/ Black/ Pink Use Form Approved. OMB No 0910-0120 Expiration oat. 06/30/2020 PRA The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Of both, applicable'

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K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color 5. Device Description : The subject device in this 510(k) Notification is a Blue Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

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