K151208 - 510(k) Premarket Notification

Trang chủ » Fda Khải Hoàn » K151208 - 510(k) Premarket Notification

Có thể bạn quan tâm

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
    • U.S. Department of Health and Human Services FDA, U.S. Food and Drug Administration U.S. Food & Drug Administration
    • Follow FDA
    • En Español
    Search FDA Search
    • Home
    • Food
    • Drugs
    • Medical Devices
    • Radiation-Emitting Products
    • Vaccines, Blood & Biologics
    • Animal & Veterinary
    • Cosmetics
    • Tobacco Products
    510(k) Premarket Notification
    • Print
    • Share
    • E-mail
    • FDA Home
    • Medical Devices
    • Databases
    -
    Super Search Devices@FDA
    510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
    CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
    New Search Back To Search Results
    Device Classification Name Polymer Patient Examination Glove
    510(k) Number K151208
    Device Name Powder Free Nitrile Examination Glove
    Applicant
    Vrg Khai Hoan Joint Stock Company
    Cau Sat Hamlet, Lai Hung Commune
    Ben Cat District,, VN
    Applicant Contact PHAM NGOC THANH
    Correspondent
    Vrg Khai Hoan Joint Stock Company
    Cau Sat Hamlet, Lai Hung Commune
    Ben Cat District,, VN
    Correspondent Contact TERENCE LIM
    Regulation Number880.6250
    Classification Product Code
    LZA
    Date Received05/06/2015
    Decision Date 09/14/2015
    Decision Substantially Equivalent (SESE)
    Regulation Medical Specialty General Hospital
    510k Review Panel General Hospital
    Statement Statement
    Type Traditional
    Reviewed by Third Party No
    Combination Product No
    Predetermined ChangeControl Plan Authorized No
    Recalls CDRH Recalls
    - -

    Links on this page:

    Page Last Updated: 12/22/2025

    Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English

    • Accessibility
    • Contact FDA
    • Careers
    • FDA Basics
    • FOIA
    • No FEAR Act
    • Nondiscrimination
    • Website Policies / Privacy
    FDA U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA
    • USA.gov
    • E-mail
    • RSS
    • Twitter
    • Facebook
    • YouTube
    • Flickr
    • For Government
    • For Press
    • Combination Products
    • Advisory Committees
    • Science & Research
    • Regulatory Information
    • Safety
    • Emergency Preparedness
    • International Programs
    • News & Events
    • Training and Continuing Education
    • Inspections/Compliance
    • State & Local Officials
    • Consumers
    • Industry
    • Health Professionals
    • FDA Archive
    • Vulnerability Disclosure Policy
    U.S. Department of Health & Human Services

    Links on this page:

Từ khóa » Fda Khải Hoàn