sterile nitrile gloves blue 510k form instructions

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Disposable Nitrile Gloves - SterileLight- sterile nitrile gloves blue 510k form instructions ,SterileLight disposable nitrile gloves are latex-free, powder-free, comfortable and super soft! They’re built to stretch and extend better than most disposable gloves. With their 3 mil thickness, textured finger tips and beaded cuff, these brand new gloves offer the user protection, value and breathability.Gloves - Cardinal HealthIn addition, all of our glove offerings are produced with the same standards of quality and service that customers have come to rely on from Cardinal Health. Surgical gloves As a leader in the industry, with over 50 years of surgical glove experience, Cardinal Health continually enhances our surgical glove portfolio to provide protection ...



AE Nitrile Disposable Gloves Powder Free Non-Sterile ...

AE GLOVE NITRILE GLOVE POWDER FREE • NON-STERILE • EXAMINATION GLOVES . Product Specifications Type : Powdered & Powder-Free, Non-sterile Material: Synthetic Nitrile Latex Colour: Blue Design & Features: Powder・Free: ... Conforms to FDA, 510(K), CE, EU, TUV ASTMD 5250, ASTMD D412, ASTMD D573

Blue Disposable Nitrile Blend Powder Free Gloves

#NitrileBlend Blue Disposable Nitrile Blend (Nitrile + Vinyl) Powder Free Examination Gloves Note: We expect these to sell quick due to huge shortage and demand of Gloves as well as our commitment to an affordable & fair pricing. Our examination Nitrile gloves are a blend of Nitrile …

July 2017 510(k) Clearances | FDA

510(k) summaries or 510(k) statements for final decisions rendered during the period july 2017 ... nitrile examination gloves, blue ug global resources sdn. bhd. 510(k) no: ... sterile nitrile ...

BLUE NITRILE Exam Glove | Halyard Health AU

Halyard Health BLUE NITRILE* Exam Gloves deliver exceptional protection for moderate to high exposure to fluids or chemicals. Blue textured fingertips enhance instrument control in both wet and dry situations. A powder-free and natural rubber latex-free design reduces potential allergic reactions and minimizes the drying effects of glove powder ...

Nitrile Gloves — Cranberry USA

NITRILE CLASSIC. Nitrile gloves are a great alternative for those that are prone to skin irritation and allergic reactions. Nitrile gloves offer the same strong durability and superior level of protection as traditional latex gloves with increased tactile sensitivity, tear resistance, and a more comfortable fit.

M. Jordan Smith

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Device Name Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Indications for Use (Describe)

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

(Polymer Patient Examination Glove) - FDA 510(k ...

comfit chemo plus powder free blue nitrile examination gloves, non sterile (tested for use with chemotherapy drug) label: 11/28/2000: k993313: wrp asia pacific sdn. bhd. comfit powder free blue nitrile examination glove, sterile: 11/23/1999: k993311: wrp asia pacific sdn. bhd. comfit powder free nitrile examination glove, sterile: 11/19/1999 ...

Nitrile Gloves Fda 510K Approved by R&Q Co Ltd. Supplier ...

Powder free Non-sterile, ambidextrous, disposable Color: blue Sizes: XS, S, M, L, XL Conformed to ASTM-D3578-01AE2 and FDA 510(k) Conformed to EN455 Part 1-3 and CE 100 pieces per box 10 boxes per carton 1,200 cartons per 20' FCL 2,400 cartons per 40' FCL

Kimberly-Clark™ Sterling™ Nitrile Exam Gloves (50708), 3.5 ...

Kimberly-Clark Sterling Nitrile Exam Gloves are low-cost nitrile glove combining the sensitivity of latex with the protection and strength of nitrile. The innovative gloves’ manufacturing technology delivers a comfortable and affordable glove with the protection and cleanliness you need. The thin mil gray gloves (3.5 mil) are ambidextrous, powder-free, have an AQL of 1.5, and feature beaded ...

Sterile Nitrile Gloves at Thomas Scientific

…ambidextrous sterile nitrile cleanroom glove is constructed from synthetic nitrile polymer. This glove contains no natural rubber latex, is silicone free and has a textured fingertip design with beaded long cuff. This glove is packaged in a cleanroom compatible plastic pouch. All Valutek gloves…

510(k) Premarket Notification

Jan 25, 2021·polymer patient examination glove: 510(k) Number: K122696: Device Name: POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) Applicant: CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD: mcgaw park, IL 60085 Applicant Contact: ... see Instructions for Downloading Viewers and Players.

Examgards® Examination Blue Nitrile Disposable Gloves ...

Exam Grade gloves feature a tight, form-fitting design; These gloves may be used for non-surgical medical tasks and for foodservice tasks; Each pair is 2.5 AQL and 510(k) cleared for medical use; Exam Grade gloves are non-sterile; Exam Grade quality provides a higher level of safety and barrier integrity; Available in Powder-Free only

INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs ...

Only US$139.80, Shop INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs/box with CE FDA 510K Blue at the Tinkleo Disposable Gloves store. Save up to 50%.

Medline Sterile Powder-Free Nitrile Exam Glove Pairs ...

Sterile nitrile exam gloves are ideal for use in the ER, burn center, pharmacy, or other areas where durable sterile protection is needed Conveniently packaged in pairs Meets both ASTM D6978-05 and USP 800 Personal Protection Equipment requirement for use of chemotherapy gloves when handling hazardous drugs**** When used in accordance to the ...

Nitrile Gloves | Nitrile Exam Gloves | Vitality Medical

Nitrile gloves are commonly used as exam gloves, but due to their strength, lend themselves to multiple uses. Nitrile gloves are made of a synthetic rubber that resembles latex, yet will have a better resistance to punctures. Nitrile comes in powdered form, sterile, non-sterile and offered at …

Medline Sterile Powder-Free Nitrile Exam Glove Pairs ...

Sterile nitrile exam gloves are ideal for use in the ER, burn center, pharmacy, or other areas where durable sterile protection is needed Conveniently packaged in pairs Meets both ASTM D6978-05 and USP 800 Personal Protection Equipment requirement for use of chemotherapy gloves when handling hazardous drugs**** When used in accordance to the ...

Standard Specification for Nitrile Examination Gloves for ...

The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have ...

Disposable Nitrile Gloves - SterileLight

SterileLight disposable nitrile gloves are latex-free, powder-free, comfortable and super soft! They’re built to stretch and extend better than most disposable gloves. With their 3 mil thickness, textured finger tips and beaded cuff, these brand new gloves offer the user protection, value and breathability.

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

Nitrile Gloves – WT GLOVES INT

Nitrile Butadiene Rubber (NBR), latex free. Color: Light Blue, Blue, White, Black, Purple, Pink. Feature: Textured, Ambidextrous, beaded cuff. Storage Condition: The gloves shall maintain their properties when stored in a dry condition at temperature not higher than 30 degrees, Avoid direct sunlight. Shelf-Life

Kimberly-Clark™ Purple Nitrile™ Exam Gloves (55082), 5.9 ...

Your valuable employees deserve the worry-free protection of Kimberly-Clark Purple Nitrile Exam Gloves. These purple nitrile gloves guard against incidental splashes, are made of a highly durable nitrile polymer and are powder free and not made with natural rubber latex (some say “latex free”). The gloves are a 9.5” long, are ambidextrous and have a beaded cuff for easy donning.

Nitrile Gloves – WT GLOVES INT

Nitrile Butadiene Rubber (NBR), latex free. Color: Light Blue, Blue, White, Black, Purple, Pink. Feature: Textured, Ambidextrous, beaded cuff. Storage Condition: The gloves shall maintain their properties when stored in a dry condition at temperature not higher than 30 degrees, Avoid direct sunlight. Shelf-Life