Halyard

Primary DI
30680651496417
Brand
Halyard
Company
O&M HALYARD, INC.
Model
49641
Catalog number
49641
Device description
HALYARD* PUREZERO* Black Nitrile Exam Gloves, XS
Published
2025-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232461000Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low DermatitisKossan International Sdn Bhd2023-11-14LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651496417PackageGS110In Commercial Distribution
20680651496410PrimaryGS10
90680651496419Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065149641730680651496417
2068065149641020680651496410
9068065149641990680651496419

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273complaints@owens-minor.com

Regulatory Flags#

DUNS number
081057389
Device count
100
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
30680651496981Halyard49698496982025-05-17
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04

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