FDA.reportPublic FDA data

Halyard

Primary DI
30680651496936
Brand
Halyard
Company
O&M HALYARD, INC.
Model
49693
Catalog number
49693
Device description
SAFESKIN,NITRILE,EXAM GLOVE,GY,SML,200
Published
2025-05-17
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651496936PrimaryGS10
90680651496938Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065149693630680651496936
9068065149693890680651496938

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
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
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
00850069531195Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedOPJ2026-10-16
00850069531010Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531157Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531171Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531188Maxter BlueMaxter Healthcare IncorporatedOPJ2026-10-15
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONOPJ2026-10-09
00199536900219BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00850005229803NeulynxMedgluv Inc.OPJ2026-07-17
00850005229810NeulynxMedgluv Inc.OPJ2026-07-17
00850005229827NeulynxMedgluv Inc.OPJ2026-07-17