FDA.report

Super Source

Primary DI
20850020042238
Brand
Super Source
Company
Super Source
Model
GLO531BK
Device description
Black Nitrile Examination Gloves – X-Large, Powder-Free, Non-Sterile, Latex-Free, Ambidextrous, Single-Use, 10 boxes (100 gloves per box)
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850020042231PrimaryGS10
20850020042238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1085002004223110850020042231
2085002004223820850020042238

GMDN Terms

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

Regulatory Flags

DUNS number
806786778
Device count
1000
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
20850020042160Super SourceGLO524B2025-05-30
20850020042177Super SourceGLO525B2025-05-30
20850020042184Super SourceGLO526B2025-05-30
20850020042191Super SourceGLO527B2025-05-30
20850020042207Super SourceGLO528BK2025-05-30
20850020042214Super SourceGLO529BK2025-05-30
20850020042221Super SourceGLO530BK2025-05-30

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