FDA.reportPublic FDA data

ADVANCE IF 40CF

Primary DI
00810120950747
Brand
ADVANCE IF 40CF
Company
Diamond Gloves
Model
NCF-40M
Device description
Powder Free Blue Nitrile Examination Gloves, Chemo Tested, Fentanyl Protection, MEDIUM
Published
2023-04-28
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
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
00810120950747PackageGS110In Commercial Distribution
00810120950730PrimaryGS10
00810120950723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810120950747008101209507478101209507470810120950747
00810120950730008101209507308101209507300810120950730
00810120950723008101209507238101209507230810120950723

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052262122
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
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00662956202558Body GuardFastenal CompanyLZA2026-09-30
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00662956205320Body GuardFastenal CompanyLZA2026-09-30
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10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
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00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03