DEVICE: PureSense (D79010684021)
Device Identifier (DI) Information
PureSense
1068402
In Commercial Distribution
1068402
PURELIFE, LLC
1068402
In Commercial Distribution
1068402
PURELIFE, LLC
PureSense Nitrile Powder-Free, Small, Nitrile powder-free gloves, Pink in color, Packaging contains recycled material
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
56286 | Nitrile examination/treatment glove, non-powdered, non-antimicrobial |
A device made of nitrile 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 patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZA | Polymer patient examination glove |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K212182 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a dry ventilated environment, do not store above 100 F (37 C), avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6efd149a-0533-4af3-9152-4bbbd7f27746
December 09, 2022
1
December 01, 2022
December 09, 2022
1
December 01, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D79010684023 | 1000 | D79010684021 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D79010684020
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)777-3303
sales@purelifedental.com
sales@purelifedental.com