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Cardinal Health Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves - HSA Registration DE0500404

Access comprehensive regulatory information for Cardinal Health Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500404 and owned by Cardinal Health. The device was registered on March 22, 2016.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0500404
Cardinal Health Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves
HSA Registration Number: DE0500404
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Product Description

This powder-free surgeon’s glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0500404
Registration Date
March 22, 2016
Change Notification Approval Date
April 22, 2025
Retention Due Date
March 21, 2026
Product Owner
Short Name
Cardinal Health
Address
3651 Birchwood Drive, Waukegan, Illinois 60085, UNITED STATES
Registrant
Address
10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510
Importer
Address
10 KALLANG AVENUE, APERIA, #10-10/18, SINGAPORE 339510 5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217
Model Information
Model Name(s)
Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 5.5 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 6.0 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 6.5 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 7.0 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 7.5 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 8.0 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 8.5 Protexis PI Sterile Polyisoprene Powder-Free Surgical Gloves , 9.0
Model Identifier(s)
2D72PT55X 2D72PT60X 2D72PT65X 2D72PT70X 2D72PT75X 2D72PT80X 2D72PT85X 2D72PT90X