FDA.reportPublic FDA data

SurgiMac

Primary DI
S4119XL1
Brand
SurgiMac
Company
Surgimac LLC
Model
DXL4119
Device description
Black Nitrile 100 ct. Extra Large
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
S4119XL1PrimaryHIBCC0
D1054119XL1Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
060635048
Device count
100
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI4MacImpressVP-9008-MIVP9008MI2026-07-06
D1051013021MacSafe10-13021013022026-06-26
D1051013031MacSafe10-13031013032026-06-26
D1051013041MacSafe10-13041013042026-06-26
D1051013011MacSafe10-13011013012026-06-25
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D1051217840MacBite12178-42025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810145952115NeuleafMedgluv Inc.OPJ2026-06-30
00810145952122NeuleafMedgluv Inc.OPJ2026-06-30
00810145952139NeuleafMedgluv Inc.OPJ2026-06-30
00810145952146NeuleafMedgluv Inc.OPJ2026-06-30
00810145952108NeuleafMedgluv Inc.OPJ2026-06-29
00850005229568NeuflexMedgluv Inc.OPJ2026-06-29
00850005229575NeuflexMedgluv Inc.OPJ2026-06-29
00850005229582NeuflexMedgluv Inc.OPJ2026-06-29
00850005229599NeuflexMedgluv Inc.OPJ2026-06-29
00850005229605NeuflexMedgluv Inc.OPJ2026-06-29
00850005229612NeuflexMedgluv Inc.OPJ2026-06-29
00810145951972NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951989NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951996NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952009NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952153NeulynxMedgluv Inc.OPJ2026-06-26
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502425HalyardO&M HALYARD, INC.OPJ2026-06-04
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