fda 510k exam vinyl gloves replacement

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(Vinyl Patient Examination Glove) - FDA 510(k ...- fda 510k exam vinyl gloves replacement ,stretch vinyl examination glove, powder free (yellow/white) 05/18/2009: k090513: shandong huayue glove co., ltd. vinyl examination glove, powder free clear (non-colored) 05/08/2009: k111752: shandong jianhong new material company: powder free vinyl patient examination gloves, clear (non-colored) 07/27/2011: k023235: shandong jiazhan plastic ...(Vinyl Patient Examination Glove) - FDA 510(k ...stretch vinyl examination glove, powder free (yellow/white) 05/18/2009: k090513: shandong huayue glove co., ltd. vinyl examination glove, powder free clear (non-colored) 05/08/2009: k111752: shandong jianhong new material company: powder free vinyl patient examination gloves, clear (non-colored) 07/27/2011: k023235: shandong jiazhan plastic ...



Do Your Gloves Comply with FDA Recommendations and ...

Jun 01, 2017·Here's what you need to know when sourcing your FDA-compliant food safety disposable gloves: What is the glove made of? - Part 177. Food contact gloves are certified under FDA Title 21 CFR Part 177, which states that the components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognized as safe for use in food or food packaging.”

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF ...

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF, Blue - Small - 100 Per Box Related Products; Customers Also Viewed; ... 3-Ply Face Mask - Level 2 ASTM (FDA 510k Medical Use) Disposable - 50 Count. $9.80. As low as $7.65. Quick view Add to Cart. 216. Quick view Add to Cart. Clear Plastic Face Shield w Foam Band (USA , FDA Facility ...

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·The FDA reviews the gloves to insure that they meet specific criteria related to safety and performance. It's important to note that many nitrile gloves have already received approval through a 510K. If you're importing nitrile gloves that have already been approved, then you won't need to go through the 510K process. You'll simply need to ...

Non-Latex, Vinyl, Powder Free Exam Gloves

Vinyl is Produced with 100% Vinyl Resin. 100% Latex Free and DEHP Free 1) Meets FDA 510K Standards for examination gloves used in medical applications. 2) These medical grade examination gloves also meet the Federal Food, Drug and Cosmetic Act which allows repeated use in …

Medical Gloves | FDA

Jun 12, 2020·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 …

China Loose Nitrile Gloves with CE + FDA + 510K + En455: 1 ...

China Loose Nitrile Gloves with CE + FDA + 510K + En455: 1, 2, 3, 4 + En374: 1, 2, 3, 4, 5, Find details and Price about China Examination Gloves White Color, Green ...

Medical Gloves for COVID-19 | FDA

Answers to frequently asked questions about medical gloves, including manufacturing, purchasing, importing, and donating gloves during the COVID-19 public health emergency.

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: vinyl patient examination glove: 510(k) Number: K132201: Device Name: SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR

US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·Sep 21, 2020·510(k) Remarks . A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. LYZ: Device Name . Vinyl Patient ...

Gloves Fda Manufacturers | Suppliers of Gloves Fda ...

clear vinyl exam gloves, powder free as per # 989901/4500798965 lot no.:chh03-01 fda 510k no.: k042952 device listing no.: d314752 size: small 25...

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K051662: Device Name: VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES …

EXAMINATION GLOVES | MEDICAL GRADE EXAM GLOVES

They are FDA 510K approved for medical use and meet USDA accepted medical exam grade glove requirements. To request a quote for larger order pallet pricing, call customer service at 800 360-8809 FREE SHIPPING IN THE CONTINENTAL U.S. ON ORDERS OVER $100.00

510(k) Premarket Notification

vinyl patient examination glove: 510(k) Number: K131344: Device Name: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES: Applicant: SHIJIAZHUANG WALLY PLASTICS CO., LTD: RM.1606, BLD.1 JIANXIANG YUAN NO.209: BEI SI HUAN ZHONG RD. HAIDIAN DISTRICT: ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For ...

510(k) Premarket Notification

Jan 25, 2021·Jan 25, 2021·Device Classification Name: vinyl patient examination glove: 510(k) Number: K132201: Device Name: SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR

510(k) Premarket Notification

vinyl patient examination glove: 510(k) Number: K131344: Device Name: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES: Applicant: SHIJIAZHUANG WALLY PLASTICS CO., LTD: RM.1606, BLD.1 JIANXIANG YUAN NO.209: BEI SI HUAN ZHONG RD. HAIDIAN DISTRICT: ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For ...

Strategies for Optimizing the Supply of Disposable Medical ...

Dec 23, 2020·Dec 23, 2020·a FDA-recognized standards for patient examination gloves include ASTM D3578-19 (latex rubber), ASTM D5250-19 (polyvinyl chloride), ASTM D6319 (nitrile rubber), and ASTM D6977 (chloroprene rubber). b Surgeon’s (surgical) gloves must be provided sterile and powderless; products meeting requirements for surgical gloves should have the mark ...

510(k) Premarket Notification

Device Classification Name: vinyl patient examination glove: 510(k) Number: K032783: Device Name: BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES

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

stretch vinyl examination glove, powder free (yellow/white) 05/18/2009: k090513: shandong huayue glove co., ltd. vinyl examination glove, powder free clear (non-colored) 05/08/2009: k111752: shandong jianhong new material company: powder free vinyl patient examination gloves, clear (non-colored) 07/27/2011: k023235: shandong jiazhan plastic ...

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·The FDA reviews the gloves to insure that they meet specific criteria related to safety and performance. It's important to note that many nitrile gloves have already received approval through a 510K. If you're importing nitrile gloves that have already been approved, then you won't need to go through the 510K process. You'll simply need to ...

FDA 510(k) Applications Submitted by ANSELL, INC.

ansell denta gloves: ansell, inc. k903107: 07/09/1990: patient exam gloves (dusted w/usp starch powder) ansell, inc. k913766: 08/22/1991: ansell no powder ambi patient examination gloves: ansell, inc. k897081: 12/19/1989: ansell conform green examination gloves: ansell, inc. k953379: 07/19/1995: hypoallergenic powdered ambidextrous coagulatn ...

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF ...

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF, Blue - Large - 100 Per Box Related Products; Customers Also Viewed; ... 3-Ply Face Mask - Level 3 ASTM (FDA-Approved Medical Use) Disposable - 50 Count. $10.97. As low as $8.56. Quick view Add to Cart. 227. Quick view Add to Cart. Arun KN95 Medical Form Fitting Mask (FDA Approved for ...

Disposable nitrile examination gloves - globalsourcesom

Synthetic As Good As Pure Nitrile Medical Glove & Vinyl Glove With All Certificates CE/FDA/510k US$ 0.091 - 0.093 / Piece 5000 Pieces Minimum Order Inquire Now Disposable Nitrile Examination Safety Gloves with CE/FDA/510k/ISO13485 US$ 0.107 - 0.109 / …

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

latex examination gloves, powder free with protein labeling claim (50 mcg or less) 06/11/1999: k021412: arista latindo industrial, ltd. p.t. latex examination gloves, powder free, polymer coated: 06/07/2002: k022987: arista latindo industrial, ltd. p.t. laxtex examination gloves, powdered contains 180 mcgm or less of total water extractable ...

FDA 510(k) Applications Submitted by ANSELL, INC.

ansell denta gloves: ansell, inc. k903107: 07/09/1990: patient exam gloves (dusted w/usp starch powder) ansell, inc. k913766: 08/22/1991: ansell no powder ambi patient examination gloves: ansell, inc. k897081: 12/19/1989: ansell conform green examination gloves: ansell, inc. k953379: 07/19/1995: hypoallergenic powdered ambidextrous coagulatn ...