FDA.reportPublic FDA data

ADVANCE IF 41

Primary DI
00810120952048
Brand
ADVANCE IF 41
Company
Diamond Gloves
Model
BPF-41XS
Device description
IF 41 Powder Free Nitrile Examination Gloves (Black) X-SMALL
Published
2024-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810120952055PackageGS110In Commercial Distribution
00810120952048PrimaryGS10
00810120952031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810120952055008101209520558101209520550810120952055
00810120952048008101209520488101209520480810120952048
00810120952031008101209520318101209520310810120952031

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.

Regulatory Flags#

DUNS number
052262122
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810120952253ADVANCE IF 36BPF-36XS2025-05-30
00810120952284ADVANCE IF 36BPF-36S2025-05-30
00810120952314ADVANCE IF 36BPF-36M2025-05-30
00810120952345ADVANCE IF 36BPF-36L2025-05-30
00810120952376ADVANCE IF 36BPF-36XL2025-05-30
00810120952406ADVANCE IF 36BPF-36XXL2025-05-30
00810120952437ADVANCE IF 42BPF-42M2025-07-01
00810120952468ADVANCE IF 42BPF-42XS2025-07-01
00810120952499ADVANCE IF 42BPF-42S2025-07-01
00810120952529ADVANCE IF 42BPF-42L2025-07-01
00810120952550ADVANCE IF 42BPF-42XL2025-07-01
00810120952581ADVANCE IF 42BPF-42XXL2025-07-01
00810120952444ADVANCE IF 42BPF-42M2025-07-01
00810120952475ADVANCE IF 42BPF-42XS2025-07-01
00810120952505ADVANCE IF 42BPF-42S2025-07-01
00810120952536ADVANCE IF 42BPF-42L2025-07-01
00810120952567ADVANCE IF 42BPF-42XL2025-07-01
00810120952598ADVANCE IF 42BPF-42XXL2025-07-01
00810120952260ADVANCE IF 36BPF-36XS2025-05-30
00810120952420ADVANCE IF 36BPF-36S2025-05-30

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00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
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