FDA.reportPublic FDA data

AMBITEX

Primary DI
00699320452004
Brand
AMBITEX
Company
Tradex Holdings LLC
Model
GDN22024
Catalog number
GDN22024
Device description
NITRILE EXAM PF 10/12/10 FM
Published
2019-04-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
20699320452008PackageGS124Not in Commercial Distribution
30699320452005PackageGS14Not in Commercial Distribution
00699320452004PrimaryGS10
70699320452003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2069932045200820699320452008
3069932045200530699320452005
00699320452004006993204520046993204520040699320452004
7069932045200370699320452003

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, sterileA sterile 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
118875127
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699320000076AMBITEXNLG200GNLG200G2021-09-02
00699320000151AMBITEXNMD200GNMD200G2021-09-02
00699320000199AMBITEXNSM200GNSM200G2021-03-06
00699320000236AMBITEXNXL200GNXL200G2021-09-02
00699320102145AMBITEXLLG800LLG8002019-04-22
00699320102220AMBITEXLSM620LSM6202019-04-05
00699320102237AMBITEXLMD620LMD6202019-04-05
00699320102244AMBITEXLLG620LLG6202019-04-05
00699320102251AMBITEXLXL620LXL6202019-04-05
00699320107911AMBITEXLXS240LXS2402019-04-05
00699320107928AMBITEXLSM240LSM2402019-04-05
00699320107935AMBITEXLMD240LMD2402019-04-05
00699320107942AMBITEXLLG240LLG2402019-04-05
00699320107959AMBITEXLXL240LXL2402019-04-05
00699320334706AMBITEX33470-433470-42019-06-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956202558Body 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
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
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