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Standard Specification for Rubber Surgical Gloves - ASTM

This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2). The gloves shall be manufactured from any rubber polymer compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements ...

ESTEEM™ Stretch Nitrile Exam Gloves | Cardinal Health

ESTEEM™ Stretch Exam Gloves are part of our High Use nitrile portfolio. These stretchable exam gloves are soft and flexible. They recover their shape quickly and effectively mold to your hands for a comfortable and protective fit. For product specifications and …

FDA Registration of Latex and Nitrile gloves - fdahelp.us

16 行·LMG Provide assistance to latex and nitrile glove manufacturers in FDA registration, 510k …

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We supply superior medical grade gloves of latex, vinyl, and nitrile materials in powder or powder-free form. Purchase FDA approved disposable work gloves now.

Appendix III. 510(k) Summary

19-02-2008·3). NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) K Number: K063 046 Product Code: LZA Intended Use: The nitrile examination gloves is a disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Manufactured by Hartalega SDN BHD 4).

Standard Specification for Nitrile Examination Gloves for ...

applied to the glove. Other lubricants may be used if their safety and efficacy have been previously established. 4.3 The inside and outside surface of the nitrile rubber examination gloves shall be free of talc. 5. Sampling 5.1 For referee purposes, gloves shall be sampled from finished product, after sterilization when labeled sterile, and ...

Registration and Listing of Medical Devices during ... - FDA

16-10-2020·Registration and listing may not be required for some facilities of authorized devices so purchasers may also verify whether specific medical devices have …

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA 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.

Nitrile Disposable Gloves | AMMEX

Nitrile Latex-free gloves have the highest chemical and puncture resistance. Highest chemical resistance Highest puncture resistance Latex-free material Our top nitrile disposable gloves Gloveworks® Orange Nitrile ...

Standard Specification for Nitrile Examination Gloves …

1. Scope. 1.1 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. 1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or ...

EXAM GLOVES, NITRILE - VARIOUS SIZES - SAM.gov

25-05-2021·Vendor must provide Nitrile Exam Gloves with standard commercial box packaging of 100 gloves or 50 pairs in order to fit most standard gloves dispenser units and documentation to support this. 12. FDA labeling requirements for both glove carton and outer case must be consistent with that reviewed by the FDA for the Vendor’s 510(k) clearance, and must minimally include the following FDA …

Our Brands | Innovative Gloves Co., Ltd | Nitrile and ...

Innovative Glove's black nitrile is the best seller amongst many distributors as it's strength is unbeatable and comfort is unimaginable. The ultra strong filler free US FDA 510K compliant black nitrile skin safe gloves provide excellent hand protection with reasonable grip at extremely competitive cost.

Heavyweight Nitrile, Powder-Free, DESCRIPTION Industrial ...

Heavyweight Nitrile, Powder-Free, Industrial-Grade, High-Visibility Orange, 7-Mil, Tractor Tread Pattern, 9.5-Inch Disposable Gloves HAND PROTECTION FEATURES • Component materials comply with FDA regulations for food contact • 100% powder-free nitrile, not made with natural rubber latex • Ambidextrous, patented, Tractor Tread

Personal Protective Equipment EUAs | FDA

03-06-2021·On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institutes of Occupational ...