nitrile gloves fda product code database

PowerPoint Presentation- nitrile gloves fda product code database ,Products name and Model: Disposable Nitrile Examination Gloves XS, S, M, L and XL Meet the provisions Of the Council Directive 93/42/EEC by and Provisions of the Regulation (EU) 2017/745 which apply to them. Examination gloves are classified as Class I medical devices in accordance with the rules set out in Annex VITI.FMC, FDA Product Code FMC - FDA Database50 行·K992337. BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN …



Kimberly-Clark Corporation JUL 1 4 2008

claimed: Gloves, Blue Colored Non-Sterile (Low Dermatitus Potential and Chemotherapy Drug Protection Labeling Claims) - K042805 Description of the device: Light gray nitrile, chlorinated,...

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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:

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Gloves PF Nitrile Small - ASD Healthcare

24-05-2021·Gloves PF Nitrile Small. Pack/Case: 200/bx. ... and the American Medical Association’s AAPC CPT® code database. Codes listed in the catalog are updated biannually by ASD Healthcare, ... Please consult the Last Updated Date and refer to the manufacturers and FDA information for …

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Nitrile Exam Gloves Powder Free, Standard Cu˜

Nitrile Exam Gloves Powder Free, Standard Cu˜ COATS® (an acronym for colloidal oatmeal system) is a patented and unique nitrile glove technology. COATS® utilises the powerful benefits of all-natural oats, an FDA-recognised skin protectant, as a coating that forms a natural, moisturising barrier between the glove and skin.

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FMC, FDA Product Code FMC - FDA Database

Pre-market Notifications for FMC. K042618. LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) LAGLOVE (M) SDN. BHD. K992337. BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA. MEXPO INTL., INC.

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Medical Device Databases | FDA

CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510(k)), product codes ...

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Medical Device Databases | FDA

CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510(k)), product codes ...

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PowerPoint Presentation

Products name and Model: Disposable Nitrile Examination Gloves XS, S, M, L and XL Meet the provisions Of the Council Directive 93/42/EEC by and Provisions of the Regulation (EU) 2017/745 which apply to them. Examination gloves are classified as Class I medical devices in accordance with the rules set out in Annex VITI.

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Product Code Classification Database | FDA

This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a …

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Search Registration and Listing | FDA

The database is updated weekly, usually every Monday. To search: Enter information in one or more boxes (fields) and select the search button.

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CE/ FDA 510K INTCO medical nitrile examination gloves

•Complies with ASTM D6319 (USA Related Product) • •Complies with ASTM F1671 • FDA 510(K) Available • Approved to use with Chemotherapy Drugs 1.100% latex free-made from durable,puncture resistant, protein and powder- free nitrile,eliminates the Type I allergic reaction associated with natural rubber latex 2.Highly elastic and super soft

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Global Medical Device Nomenclature (GMDN)

GMDN Code & FDA PT Code? To overcome the need to be a GMDN Member the FDA have a facility to assign a GMDN term to your Device record, within the GUDID Website: 1. Users can use the ‘Find FDA PT Codes’ module to search GMDN terms 2. The related FDA PT Code can be used to assign the GMDN term name to a device within the Device record.

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FDA Registration of Latex and Nitrile gloves - fdahelp.us

16 行·FDA Registration - Latex and Nitrile gloves FDA regulate latex and nitrile gloves (examination …

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LZC, FDA Product Code LZC - FDA Database

K182382. Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink. GMP Medicare SDN BHD (F25) K181130. Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs. Hebei …

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List of Global Medical Device Nomenclature (GMDN) …

03-08-2018·The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term. 01 Active implantable devices. 02 Anaesthetic and respiratory devices. 03 Dental devices. 04 Electro-mechanical devices. 05 Hospital hardware.

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Tests required for latex and nitrile gloves for FDA 510K ...

FDA Classification for examination and surgical gloves. US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are ...

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LZA, FDA Product Code LZA - FDA Database

K210944. Powder Free Nitrile Examination Glove, Tested For Use With Chemoterapy Drugs (Blue) Harbour Health LLC. K210755. Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Meditech Gloves SDN BHD. K210496. Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves.

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Class 2 Device Recall MICROTOUCH(R), NITRILE, Powder …

04-08-2011·Product Classification: examination gloves - Product Code LZC: Product: MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces,...

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Global Medical Device Nomenclature (GMDN)

GMDN Code & FDA PT Code? To overcome the need to be a GMDN Member the FDA have a facility to assign a GMDN term to your Device record, within the GUDID Website: 1. Users can use the ‘Find FDA PT Codes’ module to search GMDN terms 2. The related FDA PT Code can be used to assign the GMDN term name to a device within the Device record.

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Nitrile Gloves - safety-zone

Products » Nitrile Gloves » Available Colors. Non-Medical Packaging. Medical Packaging. NITRILE GLOVES are the perfect compromise between latex and vinyl. Nitrile is made from an allergy safe compound that feels a lot like latex but it’s much stronger, costs less, and is more comfortable to wear.

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Nitrile Powder-Free Examination Gloves

Nitrile Powder-Free Examination Gloves NON-STERILE Along with the durability and strength of nitrile, these gloves were tested using ASTM standards for permeation against 65 chemotherapy drugs and chemicals* Their ambidextrous design with textured fingertips and beaded cuff ensure a sturdy, . comfortable product, combining safety and tactile sensitivity.

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Medical Glove Guidance Manual | FDA

FDA is assessing how to revise this guidance to represent our current thinking on medical gloves. This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for ...

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Nitrile Gloves - safety-zone

Products » Nitrile Gloves » Available Colors. Non-Medical Packaging. Medical Packaging. NITRILE GLOVES are the perfect compromise between latex and vinyl. Nitrile is made from an allergy safe compound that feels a lot like latex but it’s much stronger, costs less, and is more comfortable to wear.

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Importing Medical Gloves to the USA: Info & …

15-06-2020·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 ...

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