FDA.reportPublic FDA data

AMBITEX

Primary DI
10699320702540
Brand
AMBITEX
Company
Tradex International, Inc.
Model
VLG221
Catalog number
VLG221
Device description
AMBITEX STRETCH VINYL PF LG
Published
2019-04-04
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

Product Codes#

Code, Name table
CodeName
LYZVinyl patient examination glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10699320702540PackageGS110In Commercial Distribution
00699320702543PrimaryGS10
30699320702544Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069932070254010699320702540
00699320702543006993207025436993207025430699320702543
3069932070254430699320702544

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196027981
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699320102152AMBITEXLXL800LXL8002019-04-22
00699320297025TRADEX INTERNATIONALGEN264GEN2642019-07-23
00699320297032TRADEX INTERNATIONALGEN265GEN2652019-07-23
00699320297049TRADEX INTERNATIONALGEN266GEN2662019-07-23
00699320297056TRADEX INTERNATIONALGEN267GEN2672019-07-23
00699320402627AMBITEXNSM402NSM4022019-04-05
00699320402634AMBITEXNMD402NMD4022019-04-05
00699320402641AMBITEXNLG402NLG4022019-04-05
00699320492222TRADEX INTERNATIONALGEN272GEN2722019-07-23
00699320492239TRADEX INTERNATIONALGEN273GEN2732019-07-23
00699320492246TRADEX INTERNATIONALGEN274GEN2742019-07-23
00699320492253TRADEX INTERNATIONALGEN275GEN2752019-07-23
00699320497227TRADEX INTERNATIONALGEN268GEN2682019-07-23
00699320497234TRADEX INTERNATIONALGEN269GEN2692019-07-23
00699320497241TRADEX INTERNATIONALGEN270GEN2702019-07-23
00699320497258TRADEX INTERNATIONALGEN271GEN2712019-07-23
10699320000073AMBITEXNLG200GNLG200G2021-09-02
10699320000158AMBITEXNMD200GNMD200G2021-09-02
10699320000233AMBITEXNXL200GNXL200G2021-09-02
10699320000196AMBITEXNSM200GNSM200G2021-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536905610BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905627BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905634BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905641BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905658BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27