Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

  • Model / Serial
    Lot Numbers: 0810003305, 0180007305, 0810007805, 0810015505 and 0810006705.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ansell Healthcare Products LLC, 1635 Industrial Rd, Dothan AL 36303-5750
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 0810015305.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0810007705, 0812017905 and 0810015405.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0810003405, 0810014405, 0810007905 and 0810015805.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0811015605, 0810008005, 0810014505, 0810015605 and 0811017805.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 0810003605 and 0810015705.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Canada.
  • Product Description
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
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