FDA.reportPublic FDA data

Halyard

Primary DI
30680651496981
Brand
Halyard
Company
O&M HALYARD, INC.
Model
49698
Catalog number
49698
Device description
SAFESKIN,NITRILE,EXAM GLOVE,GY,LG,400
Published
2025-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OPJMedical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231938000Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric AcidO&M Halyard, Inc.2024-03-22LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651496981PrimaryGS10
90680651496983Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065149698130680651496981
9068065149698390680651496983

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(844)425-9273complaints@owens-minor.com

Regulatory Flags#

DUNS number
081057389
Device count
2000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651718253Halyard71825718252020-11-16
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651489535HalyardO&M HALYARD, INC.OPJ2026-03-12
10857420007600EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007617EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007624EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007631EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007648EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10813172025477NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025484NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025491NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025507NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025514NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025422NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025439NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025446NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025453NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025460NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10076490788657MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductOPJ2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10860011343872BIONEXMedzah IndustriesOPJ2025-07-30
10860011343889BIONEXMedzah IndustriesOPJ2025-07-30
10860011343896BIONEXMedzah IndustriesOPJ2025-07-30
10860011725401BIONEXMedzah IndustriesOPJ2025-07-30
10860011725418BIONEXMedzah IndustriesOPJ2025-07-30
10076490708495KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490714397KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490723740KIMTECHAnsell Healthcare ProductOPJ2025-07-21
10076490737334KIMTECHAnsell Healthcare ProductOPJ2025-07-21