FDA.reportPublic FDA data

ProWorks

Primary DI
00075289122811
Brand
ProWorks
Company
TRANZONIC COMPANIES, THE
Model
GL-N105FXS
Catalog number
GL-N105FXS
Device description
ProWorks® GrizzlyNite® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, X-Small, 100/bx, 10 bxs/cs
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDAEnteroscope And Accessories
NBMVentilator,Automatic Controller,Percent Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2
NBMVentilator,Automatic Controller,Percent Oxygen

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075289122811PrimaryGS10
70075289122810Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075289122811000752891228110752891228110075289122811
7007528912281070075289122810

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.

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
007900020
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653195276400Safety ZoneBRZ640BRZ6402020-04-16
00075289715532VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
00075289715549VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
00075289715556VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
00075289715563VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
00075289715570VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25
10075289715539VIRTU-CLEANGL-NCREXSGL-NCREXS2024-11-25
10075289715546VIRTU-CLEANGL-NCRESGL-NCRES2024-11-25
10075289715553VIRTU-CLEANGL-NCREMGL-NCREM2024-11-25
70075289715562VIRTU-CLEANGL-NCRELGL-NCREL2024-11-25
10075289715577VIRTU-CLEANGL-NCREXGL-NCREX2024-11-25
10075289065009Comfort PlusCPCR200CPCR2002023-06-12
00075289065002Comfort PlusCPCR200CPCR2002023-06-12
10075289064965Comfort PlusCPR-500CPR-5002022-12-30
00075289112126ProWorksGL-L106FSGL-L106FS2020-04-02
00075289112133ProWorksGL-L106FMGL-L106FM2020-04-02
00075289112140ProWorksGL-L106FLGL-L106FL2020-04-02
00075289112157ProWorksGL-L106FXGL-L106FX2020-04-02
00075289122330ProWorksGL-N106FMGL-N106FM2020-04-02
00075289122347ProWorksGL-N106FLGL-N106FL2020-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014745003FUJIFILM Stiffening Wire (SW-2000)Fujifilm Healthcare Americas CorporationFDA2025-12-18
04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
10197106523643CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
50197106523641CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
00847627004703CD138 + Cyclin D1BIOCARE MEDICAL LLCFDA2023-06-21
04547410467284FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410324280FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410467260FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
14547410467281FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
04953170165801HANGER ADAPTER SETOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165825PROBE ARM SET AOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165849PROBE ARM SET BOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165764PROBE HANGEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
06934955960246Jade PTA Balloon Dilatation CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.FDA2020-12-25
00052569143735HealthMart STRATEGIC SOURCING SERVICES LLCFDA2020-07-31
10052569143732HealthMart MCKESSON CORPORATIONFDA2020-07-31
70075289122810ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
04547410384536FUJIFILMFUJIFILM CORPORATIONFDA2019-07-04
00811503033316Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27
10811503033306Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27
J021300030021TG-98 LM Synea 400W & H Dentalwerk Bürmoos GmbHFDA2018-08-31