DEVICE: PROTEXIS (10885380032011)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
PROTEXIS
2D72NS65X
In Commercial Distribution
2D72NS65X
Cardinal Health 200, LLC
10885380032011
GS1

1
961027315 *Terms of Use
Sterile Latex Powder-Free Surgical Gloves with Nitrile Coating
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
Yes
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47178 Hevea-latex surgical glove, non-powdered, non-antimicrobial
A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KGO Surgeon's gloves
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
3d967a68-2cf8-40e8-9470-6ee291a51a17
June 11, 2025
6
April 05, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20885380032018 50 10885380032011 In Commercial Distribution BOX
50885380032019 4 20885380032018 In Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE