medical nitrile gloves 510k medical device description list

List of Medical Gloves Manufacturers in Thailand: Our Top ...

Apr 06, 2020·Phoenix Rubber Products Company Limited (PRP) was established in 2006 as a medical latex gloves manufacturer in Bangkok. Phoenix produces 7 models of latex and nitrile gloves under the brand PROSAFE. These products are non-sterile medical gloves, general-purpose latex gloves, food handling latex gloves, extra-long latex gloves, extra-thick ...

Disposable Nitrile Gloves - Blueflame Medical

According to the 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. . . . These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification.

American Health and Safety GN925 Disposable Nitrile Gloves

Full Description. American Health and Safety™ Disposable Nitrile Exam Grade Gloves, Blue – 1,000/Case. These extra soft nitrile gloves provide exceptional fit, feel and comfort with enhanced tactile sensitivity and comfort. The textured fingertips provide an excellent grip. Complies with FDA Biocompatibility Guidance for Medical Devices.

Medical Gloves for COVID-19 | FDA

Medical Gloves for COVID-19. Medical gloves are used by health care personnel to prevent the spread of infection or illness. Medical gloves are disposable and include patient examination gloves ...

Nitrile gloves - All medical device manufacturers - Videos

Hebei Cangsu Medical Products Technology. nitrile gloves. nitrile gloves. Glove weight: 5.5 g. Glove length: 240 mm. ... Product advantages: Compared with conventional PVC gloves, nitrile Blend gloves can provide more durability, anti-aging ability, and feel softer and more comfortable. Compared ...

FDA 510k Clearance & Approval Services - I3CGLOBAL

FDA 510k Clearance. FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective, similar to that of the legally marketed device that is not subjected to PMA. Organizations planning to launch Class I, Class II, and Class III Medical Devices in the United States ...

Hongray - Nitril Gloves

VINYL/NITRILE BLENDED GLOVE. Dedicated to the glove industry for more than 20 years . Vinyl/Nitrile Blended glove containing no natural latex protein, causing no allergies, and offering affordable and effective safety and hygiene in various work environments for both medical and industrialapplications.

USA: FDA 510(k) permanent exemption for certain Medical ...

Feb 22, 2021·In order to increase the availability of certain Medical Devices in contrast to the COVID-19 health emergency, on January 15, 2021 FDA published a notice in the Federal Register which highlights the relaxation of numerous regulatory, including a waiver of Premarket Notification 510(k) requirements, that is, the Premarket notification requirements under section 510(k).

- Complete Documents (4)

510(k) Number (if known) K191279 Device Name Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs Indications for Use (Describe) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2021 See PRA Statomont below.

Medical Grade Nitrile Gloves at Thomas Scientific

N-DEX Disposable Nitrile Medical Exam Gloves, Blue, Large. Airgas Safety. …6005PF glove is a 100 percent Nitrile, non-Latex,powder-free medical grade glove which features Best's proprietary beaded and rolled cuff design. The N-DEX 6005PF glove is an ambidextrous, 9.5 inches long, 4-mil thick, packed 2,000 gloves per case.

Importing Medical Gloves to the USA: Info & Regulations ...

Jun 15, 2020·The FDA’s process for importing medical gloves to the USA. Medical gloves are class I reserved devices and are subject to general controls (section 513 (a) (1) (A) and 510 (l) (1) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c (a) (1) (A)), which include: Establishment Registration. Device Listing (CFR 21 807) – this ...

FDA 510 k Submission for Latex and Nitrile gloves ...

A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

FLEXAL™ Nitrile Medical Gloves (200-Count) • Best Darn Brands

Description Non-Sterile, Powder-Free, Latex-Free Material: Nitrile Rubber – 3.7 mil glove Color: Blue Design: Ambidextrous, textured fingertip 200-Count Box CE, FDA, FDA 510(k), ISO 9001: 2015 MODEL #:

Standard Nitrile Gloves - Respect of Florida

Nitrile Powder-Free, Fingertip Textured Examination Gloves. Latest generation nitrile material formulation features added thickness to provide excellent barrier protection and durability during extended wear. Black color offers a sleek look and versatility for various applications. Quality Assurance: FDA 510(k) Approved as a Medical Device