medical gloves fda 510k pdf instructions

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medical gloves fda 510k pdf instructions

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

Medical Glove Guidance Manual | FDA- medical gloves fda 510k pdf instructions ,This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for medical gloves. It also provides our recommendations on how to comply with the Quality System ...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 ...



FDA 510(k) Applications Submitted by MEDLINE INDUSTRIES, INC.

medline pwder-free vibnyl examiunation gloves/vinyl gloves, sterile (mds 192074,5,6) medline industries, inc. k962069: 05/28/1996: medline pre-powdered non-sterile/sterile vinyl examination gloves: medline industries, inc. k993170: 09/22/1999: medline breathable, impervious disposable surgical gowns: medline industries, inc. k042164: 08/11/2004

M. Jordan Smith

510(k) Number (if known) Device Name Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs Indications for Use (Describe) This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

GLOVE SDN BHD (Malaysia) TG MEDICAL (USA) INC. ( Listed on Main Market of Bursa Malaysia ) CORPORATION BERHAD 100% 100% 100% 100% 36.84% 97.5% 100% 100% 100% 100% 27% 100% 100% 100% 100% 74% BEST ADVANCE RESOURCES LIMITED (Labuan) GREEN RESOURCES LIMITED (Labuan) EFFICIENT PLANTATIONS CO LTD (Cambodia) 100% 100% …

Cranberry evolve™ 300 Nitrile Gloves - MED GEAR USA

BC Gloves Nitrile Gloves BC Gloves Specification Certificate - FDA, CE, EN455 Size X-Small, Small, Medium, Large, X-Large Thickness Palm / Finger - Min 0.05mm Color Blue Carton Size & …

GLOVE SDN BHD (Malaysia) TG MEDICAL (USA) INC. ( Listed on Main Market of Bursa Malaysia ) CORPORATION BERHAD 100% 100% 100% 100% 36.84% 97.5% 100% 100% 100% 100% 27% 100% 100% 100% 100% 74% BEST ADVANCE RESOURCES LIMITED (Labuan) GREEN RESOURCES LIMITED (Labuan) EFFICIENT PLANTATIONS CO LTD (Cambodia) 100% 100% …

Standard Specification for Nitrile Examination Gloves for ...

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile ...

(PDF) AN INTRODUCTION TO LATEX GLOVES

EN 455-02 Part 2-2011 Medical gloves for Single use Requirem ents and te sting for physical pr operties. EN 455-03 Part 3-2006 Medical gloves for single use

How to put on Nitrile and Latex Gloves – YourGloveSource.com

Powdered gloves will reduce the moisture and make it easier to put on gloves, however, in some industries, like automotive, cannot use powdered gloves because it is damaging to the products they work on. Additionally hospitals and medical personnel have shied away from powdered gloves due to concerns of the powder becoming air borne and thus ...

MEDICAL DEVICES: FDA regulatory pathways for medical …

market: the PMA, the 510(k), the De Novo, and the Humanitarian Device Exemption (HDE) pathways • The US FDA requires all medical device manufacturers to register their facilities, and list their devices with the agency • Once a medical device is on the US market, the manufacturers must comply with various post-marketing

The 510(k) Program - Food and Drug Administration

Learning Objectives 1. To understand medical device classifications and how classifications apply to 510(k)s 2. To describe what a 510(k) is, when it is required and the

Evaluating Chemotherapy Protection for Exam Gloves

• instructions for users to review drug labeling or material safety data sheets for the chemicals being used to determine an adequate level of protection for the intended use. (FDA Glove Guidance Manual 2008 Pg. 22) ... of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs”.

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

510(K) SUMMARY 1 of 7 The assigned 510(K) numbers: K182600 Date Prepared: November 18, 2018 1. Owner’s Identification: Mrs. Zhu Chunyan . Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000 . Tel:86-311-66179653 Fax: 86-311-66179653

How to Remove Gloves - Centers for Disease Control and ...

Peel the glove away from your body, pulling it inside out. Hold the glove you just removed in your gloved hand. Peel off the second glove by putting your fingers inside the glove at the top of your wrist. Turn the second glove inside out while pulling it away from your body, leaving the first glove inside the second. Dispose of the gloves safely.

IRB Process & Medical Devices - Pacific University

gloves) 510(k) exempt – no FDA approval required Class II – Moderate Risk (orthopedic plate) 510(k) – pre-market notification to FDA of intent to market Class III – Highest Risk (cardiovascular stent) PMA – pre-market approval from FDA ! Devices are defined and classified based on their intended use.

IRB Process & Medical Devices - Pacific University

gloves) 510(k) exempt – no FDA approval required Class II – Moderate Risk (orthopedic plate) 510(k) – pre-market notification to FDA of intent to market Class III – Highest Risk (cardiovascular stent) PMA – pre-market approval from FDA ! Devices are defined and classified based on their intended use.

Glove Layering System | PI Glove | Glove Box System | PPE ...

KEY FEATURES AND BENEFITS: This double glove-layering system offers pre-donned outer and inner gloves are packed in one poly-pouch and one inner-wrap to help make double gloving easier and faster, saving on half the donning time; and, with 50% less inner packaging materials used, reducing the impact on the environment

Cardinal Health™ Exam Gloves When it comes to safety and ...

The risk of developing a glove associated irritation can be reduced by choosing a glove that has low residual chemicals, is powder-free, and fits properly 1 With the Cardinal Health™ Low Dermatitis Potential Powder-Free Nitrile Exam Gloves, now you can treat your hands well while you treat your patients Low Dermatitis Potential

Regulations of Personal Protective Equipment (PPE) in ...

Apr 28, 2020·gloves during the pandemic. FDA suggests using medical gloves beyond shelf-life during crises where risk of transmission is low. During extended use of medical gloves between patients with no known infectious diseases, gloved hands should be cleaned between patients. Alcohol-based hand sanitizers may degrade vinyl gloves. If a glove becomes ...

Strategies for Optimizing the Supply of Disposable Medical ...

Dec 23, 2020·Conventional capacity strategies. Continue providing patient care as in usual infection control practice. Note: CDC does not recommend double gloves when providing care to suspected or confirmed COVID-19 patients. Continue use of FDA-cleared disposable medical gloves in accordance with standard and transmission-based precautions in healthcare settings and when indicated for other …

Glove Use Information Leaflet - WHO

Medical gloves are recommended to be worn for two main reasons: 1. To reduce the risk of contamination of health-care workers hands with blood and other body fluids. 2. To reduce the risk of germ dissemination to the environment and of transmission from the health-care worker to the patient and

FDA 510(k) Submission: A Step-By-Step Guide On How To ...

Jul 20, 2018·Section 4.0 – Indications for Use statement (FDA Form 3881) and Section 5.0 – 510(k) Summary are what you will find if you go searching the 510(k) database. According to CFR 21 Part 807.95(d) “ FDA will make a 510(k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that ...

Section 5: 510(k) Summary - Food and Drug Administration

510(k) Number (if known) K 131440 Device Name Powder Free Nitrile Patient Examination Gloves, Blue color (Brand Name: Titans) I ndications for Use (Describe) The Titan powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiners hand or finger to

Guide to Building a Successful 510(k) Submission

If you submit your 510(k) directly to the FDA, you must include a form 3601. For applications sent through a 3rd Party, such as Intertek, you may omit the form.. 2. CDRH Premarket Review Submission Cover Sheet . This is an optional form that is intended to provide the basic administrative information about the device and the firm submitting the 510(k) submission.

510(k) Summary Latex Examination Gloves Powder Free 1.0 ...

3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free. 5.0 Intended use of the Device Latex Examination gloves powder free is a disposable device intended for medical purpose is worn on the examiner's hand or finger to prevent contamination between patient and examiner.