DEVICE: Radians (00674326398686)

Device Identifier (DI) Information

Radians
RWG9114
In Commercial Distribution
RWG9114XL
Radians, Inc.
00674326398686
GS1

50
044600976 *Terms of Use
Powder Free Latex Examination Gloves, Blue, Non Sterile. 14 Mil. Extended Cuff. Finger Textured Grip. Single Use. Size X-Large. Tested for Use with Chemotherapy Drugs per ASTM D6978
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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?
47172 Hevea-latex examination/treatment 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 during patient examination/treatment or for other sanitary purposes; 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 various contamination. 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
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FDA Product Code

[?]
Product Code Product Code Name
LYY Latex Patient Examination Glove
LZC Medical Glove, Specialty
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Shield gloves from direct sunlight, fluorescent light, x-rays, moisture, and ozone.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: X-Large
Width: 116 Millimeter
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Device Record Status

88dfa7e0-9716-41ba-8ed7-59f5c42a37d0
January 30, 2025
1
January 22, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10674326398683 10 00674326398686 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 90674326398689 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
901-388-7776
sales@radians.com
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