FDA.reportPublic FDA data

Home Green Leaf

Primary DI
00608106000186
Brand
Home Green Leaf
Company
UNIWARE HOUSEWARE CORP.
Model
C2037M
Device description
3.7gram medical exam low derma glove
Published
2019-06-17
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
00608106000186PackageGS110In Commercial Distribution
00608106000179PrimaryGS10
00608106000193Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608106000186006081060001866081060001860608106000186
00608106000179006081060001796081060001790608106000179
00608106000193006081060001936081060001930608106000193

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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
931896372
Device count
100
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
false
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
00608106000070Home Green LeafC2037L2019-06-17
00608106000179Home Green LeafC2037M2019-06-17
00608106000230Home Green LeafC2037S2019-06-17
00608106000377Home Green LeafC2037XL2019-06-17
00608106000469Home Green LeafC2046L2019-06-17
00608106000490Home Green LeafC2046M2019-06-17
00608106000520Home Green LeafC2046S2019-06-17
00608106000568Home Green LeafC2046XL2019-06-17
00608106001206Home Green LeafC2060S2023-06-01
00608106001244Home Green LeafC2060M2023-06-01
00608106001282Home Green LeafC2060L2023-06-01
00608106001343Home Green LeafC2060XL2023-06-01
00608106001367Home Green LeafC2160S2023-06-01
00608106001381Home Green LeafC2160M2023-06-01
00608106001411Home Green LeafC2160L2023-06-01
00608106001435Home Green LeafC2160XL2023-06-01
00608106001213Home Green LeafC2060S2023-06-01
00608106001268Home Green LeafC2060M2023-06-01
00608106001299Home Green LeafC2060L2023-06-01
00608106001350Home Green LeafC2060XL2023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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