indoplas nitrile gloves blue 510k form printable

Abbreviated Premarket NotificationSumr ETS Blue Powder ...- indoplas nitrile gloves blue 510k form printable ,Abbreviated 5 10(k) Preniarket Notification 510(k) Summary ETS Blue Powder Free Nitrile Patient Exam Glove Page 2 STATEMENT OF The nitrile examination glove is a disposable device INTENDED USE: intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.510(k) Summary Latex Examination Gloves Powder Free 1.0 ...510(k) Summary Latex Examination Gloves Powder Free 1.0 Submitter:JU1G20 Company Name: Riverstone Resources Sdn. Bhd. Company Address: Lot 55, 56, No. 15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia. Contact Person: Ms. Chong Chu Mee Telephone No: +603-60283033 Fax No: + 603-60283022



CE Approved Blue Powder Free Disposable Nitrile Gloves

China CE Approved Blue Powder Free Disposable Nitrile Gloves, Find details about China Disposable, Powder Free from CE Approved Blue Powder Free Disposable Nitrile Gloves - …

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

510K Summary - Food and Drug Administration

510(k) Number (if known): K093516 Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue. Indications For Use: The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the

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

BLUE NITRILE Exam Glove | Halyard Health

Halyard Health BLUE NITRILE Exam Gloves deliver exceptional protection for moderate to high exposure to fluids or chemicals. Blue textured fingertips enhance instrument control in both wet and dry situations. A powder-free and natural rubber latex-free de

July 2017 510(k) Clearances | FDA

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2017 ... Powder-Free, Nitrile Examination Gloves, Blue UG GLOBAL RESOURCES SDN. BHD. 510(k) NO: K162510 ...

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

approved on 2/7/2000. Class I Powder Free Nitrile Examination gloves, meets all requirements of 80LZA, which ASTM D 6319-10 and FDA 21 CFR 800.20. 5.0 Description of the Device: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color -Sterile, is a disposable device Non

BLUE NITRILE Exam Glove | Halyard Health

Halyard Health BLUE NITRILE Exam Gloves deliver exceptional protection for moderate to high exposure to fluids or chemicals. Blue textured fingertips enhance instrument control in both wet and dry situations. A powder-free and natural rubber latex-free de

THE SAFETY ZONE Small Thick Blue Nitrile Exam Gloves (100 ...

Nov 23, 2020·They are form-fitting and durable, terrific for painting, 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 gloves used in ...

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

510(k) Summary Latex Examination Gloves Powder Free 1.0 Submitter:JU1G20 Company Name: Riverstone Resources Sdn. Bhd. Company Address: Lot 55, 56, No. 15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia. Contact Person: Ms. Chong Chu Mee Telephone No: +603-60283033 Fax No: + 603-60283022

Examgards® Examination Blue Nitrile Disposable Gloves ...

Exam Grade gloves feature a tight, form-fitting design; These gloves may be used for non-surgical medical tasks and for foodservice tasks; Each pair is 2.5 AQL and 510(k) cleared for medical use; Exam Grade gloves are non-sterile; Exam Grade quality provides a higher level of safety and barrier integrity; Available in Powder-Free only

Amazonom: VersaPro N101M Nitrile Exam Gloves (non-latex ...

- Medline Sensicare Non-Sterile Powder-Free Latex-Free 12 Inches Nitrile Exam Gloves, Blue, Medium, 50 Count - Sempermed Sempershield SSNF Blue Medium Nitrile Powder Free Disposable General Purpose & Examination Gloves - Medical Grade - Rough Finish - SSNF103 [PRICE is per BOX] NOTES:-----Overview: - Nitrile, Powder-Free.

BLUE NITRILE Exam Glove | Halyard Health AU

Halyard Health BLUE NITRILE* Exam Gloves deliver exceptional protection for moderate to high exposure to fluids or chemicals. Blue textured fingertips enhance instrument control in both wet and dry situations. A powder-free and natural rubber latex-free design reduces potential allergic reactions and minimizes the drying effects of glove powder ...

AMMEX Industrial Blue Nitrile 5 Mil Disposable Gloves ...

At the same time, those hands are your livelihood. Protect them with AMMEX Gloveworks Blue Nitrile Powder Free Industrial Gloves. These premium, industrial-grade gloves are an awesome combination of strength, comfort, and dexterity. More than 50 percent thicker than standard nitrile, they are durable and puncture resistant.

Kimberly-Clark™ Smooth Blue Nitrile Exam Gloves (50576), 6 ...

The distinctive blue nitrile glove color provides a visual cue if the gloves are used in the wrong place, which can help reduce the risk of cross-contamination. Kimberly-Clark™ Smooth Blue Exam Nitrile Gloves, Small, Ambidextrous, 9.5", 100 / Box, 10 Boxes, 1,000 Gloves / Case

Kimberly-Clark™ Smooth Blue Nitrile Exam Gloves (50576), 6 ...

The distinctive blue nitrile glove color provides a visual cue if the gloves are used in the wrong place, which can help reduce the risk of cross-contamination. Kimberly-Clark™ Smooth Blue Exam Nitrile Gloves, Small, Ambidextrous, 9.5", 100 / Box, 10 Boxes, 1,000 Gloves / Case

Microflex Supreno EC High-Risk Powder-Free Nitrile Exam ...

Advanced nitrile formulation offers up to 3 times the puncture resistance of latex or vinyl disposable gloves. Combined with the lowest acceptable pinhole rates (AQL 0.65) these gloves help set a new standard in protection.

Search the Releasable 510(k) Database | FDA

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

AMMEX Industrial Blue Nitrile 5 Mil Disposable Gloves ...

At the same time, those hands are your livelihood. Protect them with AMMEX Gloveworks Blue Nitrile Powder Free Industrial Gloves. These premium, industrial-grade gloves are an awesome combination of strength, comfort, and dexterity. More than 50 percent thicker than standard nitrile, they are durable and puncture resistant.

Cranberry Transcend Nitrile Exam Gloves — Cranberry USA

The Transcend Nitrile Powder Free Examination Gloves are Cranberry’s latest and strongest gloves yet, uncompromised superior formulation for high tensile strength without sacrificing tactile sensitivity that is both soft and strong with textured fingertips for precise gripping in dry and wet conditions.

Philippines Ansell Surgical Gloves: Made-in-Philippines ...

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...

Examgards® Examination Blue Nitrile Disposable Gloves ...

Exam Grade gloves feature a tight, form-fitting design; These gloves may be used for non-surgical medical tasks and for foodservice tasks; Each pair is 2.5 AQL and 510(k) cleared for medical use; Exam Grade gloves are non-sterile; Exam Grade quality provides a higher level of safety and barrier integrity; Available in Powder-Free only

510K Summary - Food and Drug Administration

510(k) Number (if known): K093516 Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue. Indications For Use: The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the

Kimberly-Clark™ Smooth Blue Nitrile Exam Gloves (50576), 6 ...

The distinctive blue nitrile glove color provides a visual cue if the gloves are used in the wrong place, which can help reduce the risk of cross-contamination. Kimberly-Clark™ Smooth Blue Exam Nitrile Gloves, Small, Ambidextrous, 9.5", 100 / Box, 10 Boxes, 1,000 Gloves / Case

510K Summary - Food and Drug Administration

NITRILE Powder-Free Exam Glove is substantially equivalent to the predicate K08 1260, KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves, and to predicate K992830, Safeskin Polymer-Coated Nitrile Examination Gloves, Traditional 510(k) Notification: KIMBERLY-CLARK* LAVENDER Section 3 - 510OK Summary Page 3 of 3

THE SAFETY ZONE X-Large Thick Blue Nitrile Exam Gloves ...

Nov 23, 2020·They are form-fitting and durable, terrific for painting, 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 gloves used in ...