FDA.reportPublic FDA data

HCS

Primary DI
20810132043721
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
6606W
Device description
3.7 Nitrile Examination Gloves, One pair, Large, Walleted, Powder-Free, Non-Sterile
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132043724PrimaryGS10
20810132043721Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081013204372410810132043724
2081013204372120810132043721

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080220245
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23
10810132043007HCS818012026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.QDO2026-07-17
00850005229827NeulynxMedgluv Inc.QDO2026-07-17
00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.QDO2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.QDO2026-07-14
00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810145952115NeuleafMedgluv Inc.QDO2026-06-30
00810145952122NeuleafMedgluv Inc.QDO2026-06-30
00810145952139NeuleafMedgluv Inc.QDO2026-06-30
00810145952146NeuleafMedgluv Inc.QDO2026-06-30
00810145952429NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952436NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952443NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952450NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952467NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952108NeuleafMedgluv Inc.QDO2026-06-29
00850005229568NeuflexMedgluv Inc.QDO2026-06-29
00850005229575NeuflexMedgluv Inc.QDO2026-06-29
00850005229582NeuflexMedgluv Inc.QDO2026-06-29
00850005229599NeuflexMedgluv Inc.QDO2026-06-29
00850005229605NeuflexMedgluv Inc.QDO2026-06-29
00850005229612NeuflexMedgluv Inc.QDO2026-06-29