FDA.reportPublic FDA data

Home Green Leaf

Primary DI
00608106000315
Brand
Home Green Leaf
Company
UNIWARE HOUSEWARE CORP.
Model
C2037S
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
00608106000315PackageGS110In Commercial Distribution
00608106000230PrimaryGS10
00608106000339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608106000315006081060003156081060003150608106000315
00608106000230006081060002306081060002300608106000230
00608106000339006081060003396081060003390608106000339

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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10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
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10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15