indoplas nitrile gloves blue 510k form pdf

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Philippines Nitrile Gloves: Made-in-Philippines Nitrile ...- indoplas nitrile gloves blue 510k form pdf ,Indoplas Nitrile Gloves. Nitrile gloves are made out of a synthetic rubber, and are an ideal alternative when latex allergies are of concern. Nitrile glove...Brand Name: indoplas, Model Number: 000876, Place of Origin: Philippines, MOQ: 10000 boxs, Type: Nitrile Glove...FDA Registration of Latex and Nitrile gloves - fdahelp.usFDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.



Cranberry Evolve 300 Nitrile — Cranberry USA

The Evolve 300 Nitrile Powder Free Examination Gloves are Cranberry’s most popular and softest gloves yet, combining comfort and tensile strength without sacrificing tactile sensitivity. Cranberry’s exclusive EvoSoft formulation gives Evolve a unique silk-like attribute that is both soft and strong

Cranberry Evolve 300 Nitrile — Cranberry USA

The Evolve 300 Nitrile Powder Free Examination Gloves are Cranberry’s most popular and softest gloves yet, combining comfort and tensile strength without sacrificing tactile sensitivity. Cranberry’s exclusive EvoSoft formulation gives Evolve a unique silk-like attribute that is both soft and strong

(Polymer Patient Examination Glove) - FDA 510(k ...

fda 510(k) number: applicant: device name: decision date: k841676: abco dealers, inc. disposable poly gloves: 05/22/1984: k972195: absolute synthetic technologies malaysia sdn. bhd. powder-free nitrile examination glove, blue or white (non-colored) 07/29/1997: k972838: absolute synthetic technologies malaysia sdn. bhd.

Section 6 510(k) Summary 510(K) Summary

Device Name: Powder Free Nitrite Patient Examination Gloves, Blue Color Company name: Jiangsu Dongling Plastic & Rubber Co., Ltd. 510(K) Number: KI 10247 4.0 Device Description: 4.1 How the device functiont: Nitrile films form a barie to body fluids and bloodborne Pathogens 4.2 Scientific concepts that form the basis for the device

Medical Nitrile Gloves Disposable Gloves | Taiwantrade.com

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: ... docx, pdf, txt, jpg, gif, png, odt, ods. Max 3 files (10MB in total). Total ...

Nitrile Gloves, Non-Latex Nitrile Gloves in Stock - Uline

Uline stocks a wide selection of disposable nitrile gloves, non-latex gloves and powder free nitrile gloves. Order by 6 pm for same day shipping. Huge Catalog! Over 37,500 products in stock. 12 locations across USA, Canada and Mexico for fast delivery of

Nitrile Examination Gloves (Indoplas) Box of 100's - LARGE ...

Nitrile Examination Gloves (Indoplas) Box of 100's - MEDIUM ₱450.00. Quick view. Nitrile Examination Gloves (Indoplas) Box of 100's - SMALL ₱450.00. Quick view. Latex Examination Gloves (Dr.Choice) Box of 100's - Medium ₱450.00. Quick view. Latex Examination Gloves (Dr.Choice) Box of 100's - Small

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

Device Name: Nitrile Powder Free Patient Examination Gloves, Blue Color . Company name: Tangshan Zhonghong Pulin Plastic Co.,Ltd. 510(K) Number: K120970 . 4.0 Device Description: 4.1 How the device functions: Nitrile films form a barrier to body fluids and bloodborne Pathogens . 4.2 Scientific concepts that form the basis for the device

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.

Microflex FreeForm SE Powder-Free Nitrile Gloves:Gloves ...

Description. Nitrile examination gloves feature a soft formulation that feels like natural rubber latex even though it's 100% latex-free. Conforms to the contours of the hand, exhibiting a degree of elasticity that allows a full range of motion.

Disposable Nitrile Gloves - Blueflame Medical

Disposable Nitrile Gloves are a critical piece of personal protective equipment (PPE.) Used during medical procedures and examinations, nitrile gloves protect both the wearer and the patient from the spread of disease, such as Covid-19. Nitrile gloves are also highly chemical and puncture resistant.

Clarence W. Murray Iii III -S

510(K) SUMMARY: K182156 2 of 5 Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978- 05(2013) and

Disposable Nitrile Gloves - Blueflame Medical

Disposable Nitrile Gloves are a critical piece of personal protective equipment (PPE.) Used during medical procedures and examinations, nitrile gloves protect both the wearer and the patient from the spread of disease, such as Covid-19. Nitrile gloves are also highly chemical and puncture resistant.

Nitrile Gloves - RFB Latex

Premium quality gloves made with our unique Nitrile formulation, for use across various Industrial and Medical applications. ADVANCED NITRILE PLUS Premium grade Nitrile gloves 280 mm as per WHO recommended specifications for enhanced protection and durability

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.

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

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 examples of examination and surgical glove 510k clearance letter

Large Thick Blue Nitrile Exam Gloves (100 Gloves/Box)

Nov 23, 2020·They are form-fitting and durable, terrific for painting, cleaning, pet care, auto care, and a wide range of other uses. Safety Zone gloves are trusted across multiple industries nationwide. Heavy duty; Textured; Medical grade; Blue; Nitrile; Disposable gloves; Dispenser box for easy storage and use; Meets FDA 510K standards for examination ...

List of Gloves Manufacturers in Vietnam: Our Top 7 Picks

Mar 24, 2020·Viet Glove JSC has 18 production lines producing latex and nitrile gloves. Viet Glove JSC manufactures its products according to the international standards such as ASTM D3578 : Standard Specification For Rubber Examination Gloves, EN 455 : Medical Gloves for Single Use, and conforms to the GMP ASEAN during the manufacturing processes.

Philippines Glove: Made-in-Philippines Glove Products ...

Indoplas Nitrile Gloves. Nitrile gloves are made out of a synthetic rubber, and are an ideal alternative when latex allergies are of concern. Nitrile glove...Brand Name: indoplas, Model Number: 000876, Place of Origin: Philippines, MOQ: 10000 boxs, Type: Nitrile Glove...

SHOWA 7502PF Biodegradable Nitrile Single Use Glove ...

SHOWA™ 7502PF Biodegradable Nitrile Single Use Glove Second-skin feel significantly reduces hand fatigue $18.50

FDA 510(k) Applications for Medical Device Product Code ...

FDA 510(k) Number: Applicant: Device Name: Decision Date: K904190: 1ST MED, INC. PATIENT EXAMINATION GLOVES: 09/19/1990: K910542: 21ST CENTURY GROUP: DIGIFLEX, LATEX ...

Cranberry Transcend Nitrile Exam Gloves — Cranberry USA

Cranberry Transcend nitrile exam gloves feature patented low Derma technology that eliminates sulfur-based chemical accelerators commonly found in nitrile gloves, reducing the potential of Type I & Type IV allergic reactions. The first Fentanyl resistance glove granted by FDA to protect against

Nitrile Glove - The World's Largest Manufacturer of Gloves

NITRILE EXAMINATION GLOVE. Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K)

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