FDA.reportPublic FDA data

Halyard

Primary DI
20680651502425
Brand
Halyard
Company
O&M HALYARD, INC.
Model
50242
Catalog number
50242
Device description
Sterling SG* SENSI-GUARD Powder-free Nitrile Exam Gloves, XL
Published
2026-06-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove
LZCMedical 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
30680651502422PackageGS110In Commercial Distribution
20680651502425PrimaryGS10
90680651502424Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065150242230680651502422
2068065150242520680651502425
9068065150242490680651502424

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
230
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651487616PUREZERO* MARIN* XTRA*48761487612022-06-06
20680651487623PUREZERO* MARIN* XTRA*48762487622022-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975073341BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073358BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073365BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371246American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371284American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZA2026-11-02
05060655503450Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503467Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503474Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26