FDA.reportPublic FDA data

DISPOSABLE NITRILE GLOVE

Primary DI
08809783490303
Brand
DISPOSABLE NITRILE GLOVE
Company
UNICO GLOBAL INC
Model
SA-2001NG
Published
2022-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809783490303PrimaryGS10
08809783490358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809783490303088097834903038809783490303
08809783490358088097834903588809783490358

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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
690513726
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809783490426SURGICAL MASKSA-2001SM2022-03-18
08809783490587Unico High Performance Surgical MaskSM-301E2022-03-18
08809783490594Unico High Performance Surgical MaskSM-301T2022-03-18
08809783490600Unico High Performance Surgical Mask With Face ShieldSM-301FS2022-03-18
08809783490617Unico High Performance Surgical Mask With Face ShieldSM-301FST2022-03-18
08809783490310FACE SHIELD MASKSA-2001FSM2022-03-18
08809783490327MEDICAL APRONSA-2001MA2022-03-18
08809783490402SURGICAL CAPSSA-2001CA2022-03-18
08809783490433SURGICAL MASK WITH FACE SHIELDSA-2001MFS2022-03-18
088097834906243PLY SURGICAL MASKFM-EU20012022-03-18
088097834906314PLY SURGICAL MASKFM-EU20022022-03-18
08809783490105Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-S2022-03-18
08809783490112Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-M2022-03-18
08809783490129Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-L2022-03-18
08809783490136Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XL2022-03-18
08809783490143Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2001S-XXL2022-03-18
08809783490150Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-S2022-03-18
08809783490167Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-M2022-03-18
08809783490174Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-L2022-03-18
08809783490181Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)SG-S2002NS-XL2022-03-18

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Primary DI, Brand, Company table
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