school health nitrile gloves blue 510k form

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Section 5: 510(k) Summary - Food and Drug Administration- school health nitrile gloves blue 510k form ,Section 5: 510k Summary 5.7 Intended Use: The Titans powder free nitrite patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.June 2020 510(K) Clearances | FDAJul 06, 2020·510 (K) SUMMARIES OR 510 (K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2020 DEVICE: ImmersiveView Surgical Plan (IVSP®) ImmersiveTouch 510 (k) NO: K181813 (Traditional) ATTN ...



510(k) Clearances | FDA

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 …

usa-angel. Curad Durable Nitrile Exam Gloves, Medium, 600 ct

Clear vinyl gloves Powder-free Latex-free Ambidextrous Form-fitting Single use only Meets the Federal Food, Drug and Cosmetic Act which allows repeated use in direct contact with food Includes 200 gloves ... Food Handling Nitrile Gloves Complies with FDA 21 CFR 177 Blue 250 gloves per box 2 boxes 500 total gloves ... single-use medical glove ...

Skymed Gloves – Pandemic Products

BRAND / TYPE: Skymed Gloves STANDARDS: CE certificate, EC Type Examination Certificate by notified body 0321, FDA 510(k) certificate, Thai FDA certificate, EN 420:2003+A1:2009, EN 421:2010, EN 374-1:2003, EN 388:2003, ISO 13485:2003, ISO 9001:2008 MATERIAL: nitrile / latex MADE IN: Thailand LOCATED IN: Thailand PRICE: please contact us directly to know the best price for your order

Amazon: Synthetic Nitrile Blue Disposable Gloves Small ...

Dre Health’s Synthetic Nitrile gloves are made from a proprietary synthetic nitrile material and is free of natural rubber latex! They are extra strong and thick, and can be used for multiple purposes. FEATURES & BENEFITS - 5 Gram Average Weight - 4 Mil Average Thickness - Single Use, Disposable - Natural Rubber Latex Free - Powder Free ...

5 Mil Nitrile at Thomas Scientific

TN100PFB Blue Nitrile Cleanroom Gloves, 9.5" Length, 5 mil Thick, Plastic Boxed. The TechniPak is the world's only Plastic (PVC) Dispenser box with 5 mil thick powder free gloves for Controlled Environments. The clean PVC box reduces particulate from paper boxes and can be wiped clean in …

Cardinal Health™ Flexal™ Nitrile Gloves - Fisher Sci

Fisher Scientific is always working to improve our content for you. We appreciate your feedback. Ok. Email this product. Cardinal Health™ Flexal™ Nitrile Gloves. Nitrile medical gloves provide tactile sensitivity and protect hands from potentially infectious materials. Subject: * missing translation for 'pleaseEnterSubject'.

Vinyl Gloves, all types Material Safety Data Sheet

All “Examination” and “Sterile” gloves, (medical use) are covered by a 510 k number, specific to the type of glove and the manufacturer who produces the glove. 510k numbers may be verified through the FDA DSMA Division, Rockville, MD. 301-443-6597 Fire & Explosion

Fact Sheet: Disposable Nitrile Gloves in Chemical Labs ...

Fact Sheet: Disposable Nitrile Gloves in Chemical Labs. Original version 12/2018, Revised 1/2019, 3/2019, 3/2021. Note: For the purpose of this Fact Sheet, the term "disposable nitrile gloves" refers to gloves that are one-time use and have a thickness of 5-mil and less. Examples are given in the tables at the end of the fact sheet.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public …

Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color . Company name: Tangshan Zhonghong Pulin Plastic Co.,Ltd. 510(K) Number: K120970 . 4.0 Device Description: 4.1 How the device functions: Nitrile films form a barrier to body fluids and bloodborne Pathogens . 4.2 Scientific concepts that form the basis for the device

usa-angel. Blue Nitrile Examination Gloves Non Latex ...

Blue Nitrile Powder Free Disposable Gloves: Blue nitrile powder free gloves are a tough, form fitting glove providing great contact and grip. Strong and durable, these offer terrific protection and are resistant to punctures and tears. Ideal for lab/medical use as …

510(k) Clearances | FDA

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 …

Nitrile Exam Gloves - Vendor Payment

High-quality Nitrile Exam Gloves. These high-quality nitrile exam gloves are powder and latex-free and protects medical and health professionals from harsh chemicals and pathogens. These gloves are ASTM D6319 and ASTM F1671 compliant and FDA and 510 (k) approved. Exam grade. ASTM D6319 and ASTM F1671 compliant.

Vinyl Gloves, all types Material Safety Data Sheet

All “Examination” and “Sterile” gloves, (medical use) are covered by a 510 k number, specific to the type of glove and the manufacturer who produces the glove. 510k numbers may be verified through the FDA DSMA Division, Rockville, MD. 301-443-6597 Fire & Explosion

Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.

Medical Glove Guidance Manual | FDA

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 ...

What You Need To Know About Nitrile Gloves ...

Jun 09, 2015·Nitrile Glove Colors: Nitrile gloves come in almost every color of the rainbow. Interestingly enough, the color of the glove does not in any way affect the quality of protection or strength offered by Nitrile gloves. Traditionally Nitrile gloves come in a blue hue in order to differentiate them as a non-latex glove for people with latex allergies.

Nitrile Gloves — Cranberry USA

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. Cranberry offers a variety of options from our Nitrile Classic series with innovative features guaranteed to fit your unique needs. CURVE FITTED.

Blue Nitrile Gloves | 24medical

Blue nitrile gloves are mainly used in the food industry and hospitals. Compared to latex and vinyl gloves, disposable nitrile gloves offer the advantage that they can be used without hesitation even with foods that are particularly fatty or oily due to their high resistance. Blue nitrile gloves, on the other hand, are popular in food ...

Disposable Gloves for Sale | Bulk Nitrile, Vinyl & TPE Gloves

510(K) Certified. The FDA requires specific certifications for medium-risk medical devices like disposable gloves. A premarket notification, or 510(k) certificate, acts as a way to verify that a new medical device is substantially equivalent to a device that’s already received approval for sale in the United States. Look for a 510(k ...

**IN-STOCK** - 1 Case of Nitrile 510k Disposable Gloves ...

**IN- STOCK** NEW* 1 Case of Nitrile 510k Disposable Gloves -- 1,000 Count Total Pieces - 10 Box (100 count) / Case- *New 4 Mil Thickness*- High Quality- Purple or Blue (color vary on availability) Other sizes may be available, please inquire. XS-XXXL

Cardinal Health Flexal Nitrile Exam Gloves by Pekara ...

Cardinal Health FLEXAL Nitrile exam gloves are truly a versatile exam glove while adding confident protection to health professionals in contact with blood-borne pathogens and infectious materials. The Cardinal Health gloves are USP compliant to also protect against laboratory chemicals and chemotherapy drugs.

School Health FitGuard Touch Nitrile Exam Gloves

FitGuard Touch Nitrile Exam Gloves,1035553FL,Medline, School Health FitGuard Touch Nitrile Exam Gloves Sensitive nitrile glove combines great tactile feel with durable nitrile protection and has textured fingertips for enhanced grip.

Community Health Trilogy Inc

Established in 2007, Community Health Trilogy is dedicated to continuously providing the lowest pricing, supplying top quality equipment. and a guarantee of delivery within 5-7 business days to hospitals, schools, corporate offices, and small business in over 20 states with ongoing protection equipment before and during the pandemic. Our stock is in the USA ready to ship so you won't have to ...

Nitrile Gloves Manufacturer | 24 Medical

Nitrile Gloves Manufacturer - 24 Medical - large capacity of nitrile gloves - quality gloves with PPE category 3 , EN 21420 , EN ISO 374 - 1: 2016, + A1: 2018, EN ISO 374 - 4 : 2019,EN ISO 374 …