medical gloves fda 510k pdf fillable

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.

Multipurpose Nitrile Gloves - Inteplast Group- medical gloves fda 510k pdf fillable ,ASTM-D0412 FDA 510K AQL: 2.5 for pinholes for medical exam grade only ISO 9001:2000 Quality Standards Before Aging 14 (min) 500 (min) After Aging 14 (min) 400 (min) ASTM Standards Nitrile exam gloves shall comply with ASTM D3578 Standard Specifications for examinations.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 …



Gloves & Respirators – MedicLink

We work with directly with factories, allocation holders and authorized distributors to supply you brands from Malaysia , Thailand & Vietnam including (Malaysia), Hartalega Coats, Paloma (Malaysia), Kimberly Clark (Malaysia) , Cranberry, Skymed (Thailand) , Sri Trang (Thailand), N Gloves (Thailand) , Shun Thai (Pure Gloves, Thailand) , which meets FDA 510K , CE and EN455 certifications.

PRODUCT SPECIFICATION FDA 510(k) NO: K080520 …

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 to prevent contamination between patient ...

Medical-Grade Disposable Gloves - Grainger Industrial Supply

Medical-grade disposable gloves have better tactile sensitivity than general purpose gloves and are worn to protect workers from biohazards and reduce the risk of contamination. These gloves can be worn alone or can be worn as part of a two-glove system where gloves are doubled to provide additional protection against contamination. They are ...

Surgical Gowns Manufacturing Basics - IFAI

Jun 16, 2020·510(k) Submission • Surgical gowns are . Class II medical devices - require 510(k) clearance. • A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least . as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Product Information

Product Superieur Nitrile Gloves FDA 510k and CE Certified Gloves Place of manufacture Thailand, Malaysia and Vietnam Configuration 100 gloves per box Size by % S, M, L, XL Thickness See spec sheets for specifics Color Blue Total Quantity TBD Delivery frequency TBD Term TBD Commencing TBD Shipping CIF Sea included.

Getting US FDA clearance for your device: Improving 510(k ...

Required FDA forms – fill these out correctly! 1. User Fee Cover Sheet (Form 3601) 2. CDRH Premarket Review Submission Cover Sheet (Form 3514) ... Follow the FDA [s 510(k) format, content, and eCopy specs Dont make the FDA assume or interpret anything – be clear and ... • FDA medical device classification • FDA Q-Sub consulting ...

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 …

Disposable Nitrile Glove Powder Free Medical Grade FDA ...

With FDA 510K certification, it can be used in a medical environment. 4mil thickness is a perfect balance between protection and comfortable fit. These gloves comply with ASTM 5250 as Medical Examination Grade. They are manufactured from materials which fully comply with FDA Rule 177.1950 for food contact and FDA rule 110.10 GMP for food ...

Your Glove Quality Is Our Priority | V GLOVES TECH

Start to process a new brand of glove in Thailand with high standard purpose. Submit to all international standards FDA 510K & CE Certification . Approved for international standard such as FDA 510K , …

Medical Devices; Patient Examination and Surgeons' Gloves ...

It is FDA's understanding, based on representations made in 510(k) Start Printed Page 75867 submissions and interactions with glove manufacturers, that the glove industry is already manufacturing gloves that meet the 1.5 and 2.5 AQLs for surgeons' and patient examination gloves, respectively. FDA recognizes that some manufacturers may decide to ...

Line Sheet - Disposable Gloves

2 This product is an FDA 510(k) approved medical glove 3 Based on finger thickness 4 Special order item. Availability and lead times may vary. † Size XXL are packed 90 gloves per box. Many competitors’ gloves fail to live up to their advertised specs. Take the guesswork out of converting business. See reverse for details. ABOVE GLOVES ARE ...

FDA 510k Clearance, Certification & Premarket Approval🥇

Traditional 510k is the original submission which normally has to be provided by the medical devices which require the FDA clearance by 510k submission according to the regulation 21 CFR 807. It can also be used to submit if there is any change in the previous FDA 510k cleared device. FDA generally takes 90 days for the traditional 510k Submission.

Gloves & Respirators – MedicLink

We work with directly with factories, allocation holders and authorized distributors to supply you brands from Malaysia , Thailand & Vietnam including (Malaysia), Hartalega Coats, Paloma (Malaysia), Kimberly Clark (Malaysia) , Cranberry, Skymed (Thailand) , Sri Trang (Thailand), N Gloves (Thailand) , Shun Thai (Pure Gloves, Thailand) , which meets FDA 510K , CE and EN455 certifications.

Personal Protective Equipment (PPE) and COVID-19: FDA ...

Sep 22, 2020·Medical Gloves Medical gloves are used to protect the wearer from the spread of infection during medical procedures and examinations. Medical gloves are class I devices that require a 510(k) clearance, and include patient examination gloves (21 C.F.R. §880.6250) and surgical gloves (21 C.F.R. §878.4460). Medical Gowns

Appendix III. 510(k) Summary

Feb 19, 2008·510(k) Number: ('< 2 ' Device Name: Latex Examination Gloves (Powdered and Powder-Free) Nitrile Examination Gloves (Powdered and Powder-Free) Indications for Use: A patient examination glove is disposable devices intended for medical purpose that is worn on the hand or finger(s) to prevent contamination between patient and examiner.

Gloves - irp-cdn.multiscreensite.com

The MG Glove Company is the result of a recent acquisition of a historic market leader in the glove manufacturing industry. The actual MG Glove manufacturing plant located in provinces of Krabi, in the south of Thailand. commenced our operations by producing latex gloves for various medical …

FDA Updates Medical Glove Recommendations

Feb 15, 2008·The FDA has updated its recommendations for makers of medical gloves in a guidance covering testing, importation and 510(k) submissions. Gloves used for biocompatibility studies must contain the same colorants, fragrances, flavors, powders, lubricants and processing chemicals as finished products, the guidance says.

FDA 510(k) Applications Submitted by SDN. BHD.

fda 510(k) number submission date device name applicant; k9134: 07/30/1991: latex examination gloves: sdn. bhd. k122999: /27/2012: powder free nitrile examination gloves, tested for use with chemotherapy drugs: sdn. bhd. k990468: 02/16/1999: latex examination glove w/ low protein labeling: sdn. bhd. k021855: 06 ...

Disposable Nitrile Glove Powder Free Medical Grade FDA ...

With FDA 510K certification, it can be used in a medical environment. 4mil thickness is a perfect balance between protection and comfortable fit. These gloves comply with ASTM 5250 as Medical Examination Grade. They are manufactured from materials which fully comply with FDA Rule 177.1950 for food contact and FDA rule 110.10 GMP for food ...

PRODUCT SPECIFICATION FDA 510(k) NO: K080520 …

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 to prevent contamination between patient ...

Ansell Healthcare Products, LLC. 2301 Robb Drive ...

FORM FDA 3881 (7/17) Page 1 of 2 PSC Publishing Services(301) EF443-6740 510(k) Number (if known) . K190018 . Device Name . Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs

Lenora Glove PVT LTD. ℅ Manoj Zacharias

lenora glove pvt.ltd. submission of premarket notification (510k) for latex surgeon’s glove powder free page 1 of 7 . 510k summary as required by: 21cfr § 807.92 k190632

Line Sheet - Disposable Gloves

2 This product is an FDA 510(k) approved medical glove 3 Based on finger thickness 4 Special order item. Availability and lead times may vary. † Size XXL are packed 90 gloves per box. Many competitors’ gloves fail to live up to their advertised specs. Take the guesswork out of converting business. See reverse for details. ABOVE GLOVES ARE ...

FLEXAL™ Nitrile Medical Gloves | Cardinal Health

Footnotes and references: *GHX/ HPIS D_MAT2015 1 Caution: Gloves used for protection against chemotherapy drug and laboratory chemical exposure should be selected specifically for the type of chemicals being used. 2 This Cardinal Health product helps healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.. Note: Review Safety Data Sheets (SDS) …