Halyard

Primary DI
10809160542125
Brand
Halyard
Company
MEDICAL ACTION INDUSTRIES INC.
Model
SWDS007
Published
2026-10-28
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

Product Codes#

Code, Name table
CodeName
KGOSurgeon's gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103714000ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAAnsell Healthcare Products, LLC2011-07-07KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160542122PackageGS125In Commercial Distribution
10809160542125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916054212220809160542122
1080916054212510809160542125

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; 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 both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160542019HALYARDDUGR84-012026-10-28
10809160542026HALYARDDUYV76-032026-10-28
10809160542033HALYARDDAHA30-022026-10-28
10809160542040HalyardDRRD93-012026-10-28
10809160542057HALYARDDUAV18-022026-10-28
10809160542064HalyardDUMD33-012026-10-28
10809160542071HalyardDUTC93-012026-10-28
10809160542088HalyardDAAU122026-10-28
10809160542095HALYARDDUMF13-022026-10-28
10809160542101HalyardDRNE38-022026-10-28
10809160542118HalyardLCOD005-012026-10-28
10809160542132HalyardSWDS0062026-10-28
10809160542149HalyardDRPM81-012026-10-28
10809160542156HalyardWH0022-032026-10-28
10809160542170HalyardGUNH004-052026-10-28
10809160542187HalyardHWEX25-012026-10-28
10809160542194HalyardSCAV001-032026-10-28
10809160541784HALYARDDUTY24-022026-10-27
10809160541791HALYARDLLOF5109-052026-10-27
10809160541807HalyardDUNE88-012026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
00755676002369mvetADI MedicalKGO2026-10-26
00755676002376mvetADI MedicalKGO2026-10-26
00755676002413mvetADI MedicalKGO2026-10-26
00755676002437mvetADI MedicalKGO2026-10-26
00755676002451mvetADI MedicalKGO2026-10-26
00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
10809160538968HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-24
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10304040195038CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.KGO2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.KGO2026-07-29
09001570557278Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.KGO2026-05-21