disposable nitrile gloves blue 510k form template

Medcare Nitra Force Nitrile Examination Gloves by ...

We can now offer Medcare Nitrile Examination Gloves, directly delivered in Europe, in Asia and in the USA. Medcare Nitrile Examination Gloves has FDA, CE, EN 455-1, EN 455-2, EN 455-3, EN 455-4, EN 374, EN 420 and ASTM D6319. Boxes of 100 pieces: 200K boxes till 1M boxes is USD$ 8.80 (CIF Europe and USA) 1M boxes till 5M boxes is USD$ 8.70 (CIF Europe and USA) 5M boxes till 10M …

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 – Global Gain Enterprises

VGLOVE NITRILE GLOVES. Vietnam Production of Natural rubber latex-free & powder-free gloves. The cuff is rolled for strength and the fingertips are textured for a better grip. Fingers & Pams: 0.05mm. Bracelet: 0.04 mm. CE, FDA & ISO 9001, ISO 13485, ISO 22000 certified. 100 gloves …

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.

Medical Nitrile Gloves Disposable Gloves | Taiwantrade

Dec 08, 2020·Detailed info about Medical Nitrile Gloves Disposable Gloves. Contact Taiwan Medical Glove supplier-OZER INTERNATIONAL CORP. for disposable gloves, nitrile gloves, medical gloves, examination gloves on Taiwantrade. ... Blue: Certified: iso 9001: iso 13485: FDA 510K: Last Update : 2020-12-08. ... Step 1Fill in the form Step 2Completion. Mr.K. Y ...

Halyard Health Christine Macauley Regulatory Affairs ...

510(k) Summary (K180646) Page 3 of 5 Indicat ions for Use The Halyard Lavender Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs listed on the label.

Nitrile Glove by Invulner Armour Co., Ltd. Supplier from ...

Size - M Brand - HoneyWell Colour - Blue Item dimensions L x W x H - 20.4 x 11 x 6.8 centimetres Number of pieces - 100 About this item Durable and comfortable disposable gloves feature a smooth exterior finish with textured fingertips and a beaded cuff Offer improved resistant to punctures, tears, and rips compared to latex or vinyl ...

Medcare Nitra Force Nitrile Examination Gloves by ...

We can now offer Medcare Nitrile Examination Gloves, directly delivered in Europe, in Asia and in the USA. Medcare Nitrile Examination Gloves has FDA, CE, EN 455-1, EN 455-2, EN 455-3, EN 455-4, EN 374, EN 420 and ASTM D6319. Boxes of 100 pieces: 200K boxes till 1M boxes is USD$ 8.80 (CIF Europe and USA) 1M boxes till 5M boxes is USD$ 8.70 (CIF Europe and USA) 5M boxes till 10M …

Supérieur Nitrile Examination Gloves | LUXITA for LIFE

Disposable nitrile examination gloves, powder free, latex free, non-sterile, textured, ambidextrous ... medical, dental, procedures, chemotherapy, patient care, food handling. Color: White / Black / Blue . Compliance. FDA 510(k) ASTM D6319, ASTM D6978 (Chemotherapy) ISO 13485:2016, ISO 9001-2015. EN ISO 374-1:2016, EN ISO 374-2:2014, EN ISO 374 ...

December 21, 2018 Shanghai Truthful Information Technology ...

Blue/ Black/ Pink Color . 510(k) number: K171422 . 5.0 Indication for Use The Nitrile Glove Powder Free White is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. 6.0 Device Description The proposed device is Powder Free Nitrile Examination Gloves. The

Search the Releasable 510(k) Database | FDA

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

4 mil Disposable Nitrile Gloves - 510(k) - Rocket.direct ...

Our medical grade Nitrile Examination Gloves -510(k) are 100% latex and powder-free featuring a 4mil thickness. Medical grade 100% Nitrile (non-blend), Textured finger. Available in S, M, L and XL sizes. Authorized US distributors of Kingfa Medical products

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.

510K Summary - Food and Drug Administration

510(k) Number (if known): K093516 Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue. Indications For Use: The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the