FDA.reportPublic FDA data

PUREZERO* MARIN* XTRA*

Primary DI
20680651487623
Brand
PUREZERO* MARIN* XTRA*
Company
O&M HALYARD, INC.
Model
48762
Catalog number
48762
Device description
HYH,LFS,PUREZERO GLOVE,BU,S
Published
2022-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove
LZCPatient examination glove, specialty
OPJMedical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651487620PackageGS110In Commercial Distribution
20680651487623PrimaryGS10
90680651487622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065148762030680651487620
2068065148762320680651487623
9068065148762290680651487622

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)645-7042CSInforequest@owens-minor.com

Regulatory Flags#

DUNS number
081057389
Device count
50
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651487616PUREZERO* MARIN* XTRA*48761487612022-06-06
20680651487630PUREZERO* MARIN* XTRA*48763487632022-06-06
20680651487647PUREZERO* MARIN* XTRA*48764487642022-06-06
20680651487654PUREZERO* MARIN* XTRA*48765487652022-06-06
20680651487661PUREZERO* MARIN*48766487662022-06-06
20680651487678PUREZERO* MARIN*48767487672022-06-06
20680651487685PUREZERO* MARIN*48768487682022-06-06
20680651487692PUREZERO* MARIN*48769487692022-06-06
20680651487708PUREZERO* MARIN*48770487702022-06-06
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17
30680651496974Halyard49697496972025-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZC2026-10-07