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2022-6-18 · Disposable nitrile gloves without powder and disposable nitrile gloves with powder; resistant and professional nitrile gloves of different colors: black, white, green and blue. Nitrile gloves were conceived as an alternative to Latex gloves for use in allergic subjects and to reduce the sensitization to Latex proteins, but the current large ...
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2021-12-29 · Page 2 of 6 III. PREDICATE DEVICE Predicate Device Name JR MEDIC Blue Nitrile Examination Gloves Powder Free 510(k) Number K192333 Regulation Number 21 CFR 880.6250 Class I Product Code LZA IV. DEVICE DESCRIPTION ATM® Glove Powder free Nitrile Examination gloves is a Class I device bearing the product code LZA (21CFR 880.6250).
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2022-4-4 · www.fda.gov April 3, 2022 Protect Gloves Co., Ltd. ℅ Paweena U-Thainual CEO MDR Solutions Co., Ltd. ... Trade/Device Name: ELAZ Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved ... D Prescription Use (Part 21 CFR 801 Subpart D ...
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2022-6-3 · 4. Maxiflex 34-874 Ultimate Nitrile Work Gloves. If you are interested in Maxiflex gloves then the brand’s 34-874 Ultimate Nitrile Work Glove is surely going to satisfy you. It is a great option, even for those who have sensitive …
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2018-10-8 · These gloves should meet the current FDA-recognized consensus standard for patient examination gloves or an equivalent test method. We recommend that you follow the 510(k) format for examination ...
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Disposable Glove Type Medical-Grade; Finger Thickness 3.8 mil; Latex-Free Yes; Length 9 1/2 in; Material Nitrile; Medical Glove Type Exam; Palm Thickness 2.4 mil; Powdered/Powder-Free Powder-Free; Silicone-Free No; Standards FDA 21 CFR 177, FDA 510K; Sterile/Non-Sterile Non-Sterile; Texture Grain; Texture Location Fingertips; Glove Treatments ...
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2022-6-9 · March 21, 2016. Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. …
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2022-6-18 · Disposable nitrile gloves without powder and disposable nitrile gloves with powder; resistant and professional nitrile gloves of different colors: black, white, green and blue. Nitrile gloves were conceived as an alternative to Latex gloves for use in allergic subjects and to reduce the sensitization to Latex proteins, but the current large ...
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2021-11-12 · www.fda.gov November 11, 2021 Jiangsu Jinlian Medical Technology Co., Ltd ... China Re: K212497 Trade/Device Name: Nitrile Examination Glove (Powder free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved ... E Prescription Use (Part 21 CFR 801 Subpart D) …
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2022-6-11 · On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves ...
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2022-6-9 · March 21, 2016. Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. …
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2022-6-9 · March 21, 2016. Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. …
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