TRANZONIC COMPANIES, THE

Address:2530 Westcott Blvd,Knoxville,TN,37931,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Polymer Patient Examination Glove (LZA) (6) Latex Patient Examination Glove (LYY) (4)

Premarket Exempt

No Yes

Clear

ProWorks - 00075289145087 Catalog Number : GL-N107FL

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, Large ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289145094 Catalog Number : GL-N107FX

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, X-Lar ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, X-Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289145100 Catalog Number : GL-N107FXX

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, XX-La ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 6 mil, XX-Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289145155 Catalog Number : GL-L113FS

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 6.5 mil, S ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 6.5 mil, Small, 50/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

ProWorks - 00075289145162 Catalog Number : GL-L113FM

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 13 mil, Me ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 13 mil, Medium, 50/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

ProWorks - 00075289145179 Catalog Number : GL-L113FL

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 13 mil, La ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Dark Blue, 13 mil, Large, 50/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

ProWorks - 00075289145186 Catalog Number : GL-L113FX

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 6.5 mil, X-L ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 6.5 mil, X-Large, 50/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

ProWorks - 00075289145193 Catalog Number : GL-NB107FS

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Small, ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Small, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289145209 Catalog Number : GL-NB107FM

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Medium ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Medium, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289145216 Catalog Number : GL-NB107FL

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Large, ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue, 6 mil, Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

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