medical nitrile gloves 510k medical device submissions

Billing Code: 4150-26 - HHS

Medical devices are generally subject to FDA premarket review in one of two forms. The first is premarket approval (PMA) review under section 515 of the FD&C Act, 21 U.S.C. 360e. This form of “rigorous” review, analogous to FDA review of a New Drug Application for ... clinical study to support a 510(k) submission for a MRSA point-of-care ...

FDA Permanently Exempts Seven Class I Gloves from 510(k ...

Jan 28, 2021·Through the Notice, HHS identified seven class I devices—all medical gloves—as exempt from the 510(k) premarket notification requirements. The newly exempt gloves include: Device …

NITRILE GLOVES | ISC

type - nitrile powder free gloves, 3.5 mil. manufacturer - hartalega sdn. bhd standards - iso / astm d6319 / astm 6978 / en455 part 1,2,3,4 / en 420 certifications - fda 510(k) / ce / rohs / ppe 89 use - suitable for healthcare workers in infectious bacteria zones

FDA immediately exempts 7 medical devices from the 510(k ...

Jan 15, 2021·The COVID-19 public health emergency brought about a sudden and unexpected need for personal protective equipment and other medical devices. In response, the Food and Drug Administration (FDA) issued a number of guidance documents that, among other things, waived the premarket notification (510(k)) requirement for the lawful distribution of these devices during the …

Detailed FDA 510k Submission - I3CGLOBAL

Pre-Submission or Q-Submission allows the manufacturer/applicant to request formal feedback on the 510k files of your medical device, specifically on (a) test protocols (b) substantial equivalence, (c) missing section, etc. before you make an FDA review payment and submit a 510k application.

FDA 510(k) Applications Submitted by Zhonghong Pulin ...

Sep 21, 2015·FDA 510 (k) Number. Submission Date. Device Name. Applicant. K171873. 06/23/2017. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs. Zhonghong Pulin Medical Products Co., Ltd. K152712.

510k Myth - Not Required for Class 1 Medical Devices - PPE ...

Dec 16, 2020·510K Myths. 510K - NOT required for Class 1 medical devices - Period. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.

What's the Difference Between Medical and Non-Medical Gloves?

Nov 05, 2020·Medical gloves belong to medical devices in THE European Union, and shall be marked with CE according to eu medical Devices Directive 93/42/EEC(MDD) or EU Medical Devices Regulation 2017/745/(MDR). The corresponding standard is EN 455-1/EN 455-2/ EN 455-3/ EN 455-4.

Nitrile Examination Gloves – J7 International Inc.

V-GLOVE - NITRILE EXAMINATION GLOVES - 510K / Latex Free. V-Glove Nitrile Examination Gloves are powder-free, 100% latex-free to avoid the risk of potential allergies providing superior strength and puncture-resistance for safe use with a variety of materials. Fully textured fingertips provide enhanced wet and dry grip.

CALIFORNIA PROPOSITION 65 AND VINYL EXAM GLOVES

valuable role in the medical and industrial glove market. Vinyl exam gloves are regulated at the federal level by the FDA as medical devices that require Premarket submissions (510(k)) prior to commercial distribution. The exam gloves have FDA cleared 510(k)s that demonstrate that they

Top 10 Benefits of Nitrile & Disposable Gloves For COVID ...

This is the standard specification made for nitrile examination gloves used for medical applications. You also have the 510(k) Premarket Notification that checks for safe and effective medical devices. This is a premarket submission that is made to the FDA. It helps demonstrate if a device in question can be legally marketed.

SUPERIEUR - NITRILE EXAM GLOVES - Powder Free - FDA 510K ...

Product Type: Gloves. DESCRIPTION. Superieur nitrile gloves are a strong solution for medical and multi-purpose applications. A high production manufacturer of quality nitrile and vinyl glove products. Product Information Sheet. Manufacturers Product Sheet. FEATURES.

Firstgulfmedical

First Gulf Medical Supplies LLC in Dubai is the exclusive distributor for different Nitrile Gloves brands Medical and Non Medical grade, in the GCC Countries. Our speciality are Nitrile Gloves Medical Grade needed by hospitals or clinics. The standards followed are: EU Standards. USA- FDA 510K

FDA 510(k) Applications Submitted by Zhonghong Pulin ...

Sep 21, 2015·FDA 510 (k) Number. Submission Date. Device Name. Applicant. K171873. 06/23/2017. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs. Zhonghong Pulin Medical Products Co., Ltd. K152712.