nitrile gloves fda product code database

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Chemical Resistance Guide- nitrile gloves fda product code database ,Gloves should be removed and replaced immediately if incidental splash exposure occurs. Precaution: This data was generated from the KIMBERLY-CLARK * STERLING Nitrile Exam Gloves. This data does not represent gloves thinner than the STERLING* Nitrile glove, such as the KLEEN-GUARD* G10 Arctic Blue Nitrile Gloves.00612479249608 GUDID Code | 14-6N64C Model | MCKESSON ...The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Device Description: GLOVE, EXAM NITRILE BLUE CONFIDERM 6.8C PF MEDIUM 9” CUFF: Additional relevant information about the device that is not already captured as a distinct GUDID data attribute.



Nitrile gloves powder-free EN455, CE, FDA, EN374-5, EN374 ...

Wholesale nitrile gloves SRITRANG Nitrile gloves powder-free EN455, CE, FDA, EN374-5, EN374-1 Our company has been importing single-use medical products since t | merkandiom

Nitrile Glove | MSCDirectom

Non powdered or powder free gloves are used in hospitals, food processing and industrial applications where contamination is a concern. Nitrile is a synthetic rubber that has anti-microbial properties and is resistant to acid, chemicals, oils, solvents, greases and petroleum-based fluids.

Nitrile Glove | MSCDirectom

Non powdered or powder free gloves are used in hospitals, food processing and industrial applications where contamination is a concern. Nitrile is a synthetic rubber that has anti-microbial properties and is resistant to acid, chemicals, oils, solvents, greases and petroleum-based fluids.

Blue Nitrile Gloves - Farnell

FDA Registered Manufacturer CE Classification: Class 1 Non Sterile - Minimal Risk Shelf Life: 3 years Glove Care: Never store in direct sunlight or near heat. Product Code: Size: Width (mm): Length (mm): Min Force at Break: Thickness at Palm: tbc Extra Small <80mm 240min 6N 0.10mm +0.02mm tbc Small 80 + 10 240min tbc Medium 95 + 10 240min

Nitrile Gloves - Safety Zone

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. Nitrile is perfect for demanding applications, especially cleaning and dishwashing. Our lightly powdered versions are produced with a ...

Quality Assurance Manager Lot 1, Jalan 3, Kawasan ...

Product Code: LZA . 3.0 Predicate Device: K133168 . Dermagrip Powder Free Blue Nitrile Examination Gloves . WRP Asia Pacific Sdn Bhd . 4.0 Description of The Device: Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.

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

Jun 15, 2020·The FDA does not intend to object to the distribution and use of surgeon’s gloves that do not comply with the following regulatory requirements where the surgeon’s gloves do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,31 ...

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

Jan 19, 2009·Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC 510(K) Number: K190080 3.0 Predicate Device Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

Fda Approved Nitrile Gloves | MSCDirectom

Non powdered or powder free gloves are used in hospitals, food processing and industrial applications where contamination is a concern. Nitrile is a synthetic rubber that has anti-microbial properties and is resistant to acid, chemicals, oils, solvents, greases and petroleum-based fluids.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

Jan 19, 2009·Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC 510(K) Number: K190080 3.0 Predicate Device Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

China Nitrile Gloves Fda, Nitrile Gloves Fda Wholesale ...

China Nitrile Gloves Fda wholesale - Select 2021 high quality Nitrile Gloves Fda products in best price from certified Chinese Fda manufacturers, Fda Standard suppliers, wholesalers and factory on …

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.

US FDA Medical Device Labeling Requirements - Gloves

US FDA Medical Device Labeling Requirements - Gloves US FDA define label as "display of written, printed, or graphic matter upon the immediate container of any article". There are specific labeling requirements for examination and surgical gloves (nitrile and latex).

PRODUCT SPECIFICATION Nitrile Powderfree Examination ...

May 31, 2011·PRODUCT SPECIFICATION Nitrile Powderfree Examination Gloves (Textured) SECTION I: PRODUCT DESCRIPTION 1. 1 Type Nitrile Examination Glove, Powderfree, Non-sterile 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color ( Pigment ) o Off white o Blue o Black 1. 4 Design and Feature Ambidextrous, textured, beaded cuff 1. 5 Powder No powder ...

Search Registration and Listing | FDA

Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332)

FDA 510 K premarket submission, notification, clearance

Assistance in transfer of 510k review fees to FDA; Assistance in Establishment registration with FDA; Assistance in Device Listing with FDA; 510k approval process flow diagram. FDA Registration - Latex and Nitrile gloves. Tests required for latex and nitrile gloves - FDA Submission . Biocompatibility tests required for examination and surgical ...

PRODUCT SPECIFICATION FDA 510(k) NO: K080520 Patterson ...

PRODUCT SPECIFICATION FDA 510(k) NO: K080520 . Patterson Nitrile PF . PRODUCT Nitrile examination glove . Medical grade . Non-sterile . Powder-free . Inner coating . Textured fingertips . COUNTRY OF ORIGIN Thailand . INTENDED USE This is a disposable device intended for medical purposes that is worn on the examiner’s hand

00861003000219 GUDID Code | D Model | HOSPI CORPORATION ...

FDA Premarket submission is not required for this device. Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) FALSE: Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. Kit: TRUE

Fda Approved Nitrile Gloves | MSCDirectom

Non powdered or powder free gloves are used in hospitals, food processing and industrial applications where contamination is a concern. Nitrile is a synthetic rubber that has anti-microbial properties and is resistant to acid, chemicals, oils, solvents, greases and petroleum-based fluids.

00861003000226 GUDID Code | B Model | HOSPI CORPORATION ...

Global Unique Device ID: 00861003000226. Version (Model) Number: B. Device Name: Convenience tray for the Macy Catheter. Contents include: Macy Catheter, 60ml Enteral/Oral Syringe, 10ml Enteral/Oral Syringe, 3ml Enteral/Oral Syringe, (2) 10ml Pre-filled Balloon Inflation Syringes, Macy Catheter Instructions for Use, 3-Ply Poly Towel, Nitrile Gloves, Lubricating Jelly, Catheter Securing …

Regulatory Alert: FDA Import Requirements for Personal ...

designated by FDA Intended Use Code 940.000: Compassionate Use/Emergency Use Device. Below is a list of some products and their FDA product codes that are currently authorized by an EUA. A full list is included in the References section. • Diagnostic tests with product codes: 83QPK, 83QKO, 83QJR • Masks/respirators with product code: 80NZJ

Product Classification - Food and Drug Administration

Jan 25, 2021·10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

PRODUCT SAFETY DATA SHEET - Smith & Nephew

Apr 13, 2017·Manufacturer’s Product Code Various USE For use as patient examination gloves. Note: NOT for use with chemicals, unless this type of nitrile glove has been confirmed to be suitable by the chemical supplier. PHYSICAL DESCRIPTION / PROPERTIES Appearance and Odour Glove made from 100% synthetic nitrile polymer. Packed in a dispenser box.

November 30, 2018 Hongray USA Medical Products Inc ...

Trade / Product Name: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) Common Name: Exam Gloves . Classification Name: Non-powdered patient Examination Classification Regulation: 21 CFR 880.6250 . Product Code: LZA, LZC Classification Panel: General Hospital Device Class: Class I . 3. Predicate Device ...