FDA.report

Azur

Primary DI
D79010617013
Brand
Azur
Company
PURELIFE, LLC
Model
1061701
Catalog number
1061701
Device description
Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D79010617013PackageHIBCC2000In Commercial Distribution
D79010617011PrimaryHIBCC0
D79010617010Unit of UseHIBCC0

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
877-777-3303sales@purelifedental.com

Regulatory Flags

DUNS number
828690904
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D790106840210685020PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685030PureOrthoSense10684031068503106840310685032025-03-20
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D790106840510685050PureOrthoSense10684051068505106840510685052025-03-20
D79010201010PureSkin102010110201012023-09-22
D79010201020PureSkin102010210201022023-09-22
D79010201030PureSkin102010310201032023-09-22
D79010201040PureSkin102010410201042023-09-22
D79010201050PureSkin102010510201052023-09-22
D79010217010PureBliss102170110217012023-09-22
D79010217020PureBliss102170210217022023-09-22
D79010217030PureBliss102170310217032023-09-22
D79010217040PureBliss102170410217042023-09-22
D79010217050PureBliss102170510217052023-09-22
D79010681010PureOnyx106810110681012023-09-22
D79010681020PureOnyx106810210681022023-09-22
D79010681030PureOnyx106810310681032023-09-22
D79010681040PureOnyx106810410681042023-09-22

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