TRANZONIC COMPANIES, THE

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

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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

Latex Patient Examination Glove (LYY) (4) Polymer Patient Examination Glove (LZA) (4) Pad, Menstrual, Unscented (HHD) (2)

Premarket Exempt

No Yes

Clear

Maxithins - 00075289047701 Catalog Number : MT200

Device Description : MAXITHINS REGULAR MAXI W/WINGS VEND PACK 200/CS

Device Class : 1

Duns Number: 007900020

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 1

Enviro Gards - 00075289064913 Catalog Number : EGP200

Device Description : ENVIRO GARDS VENDED ORGANIC SANITARY NAPKIN W/WINGS 200/CS

Device Class : 1

Duns Number: 007900020

Premarket Exempt : Yes

Product Code : HHD

Prescription Use : No

Device Count : 1

ProWorks - 00075289112126 Catalog Number : GL-L106FS

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Small ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Small, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

ProWorks - 00075289112133 Catalog Number : GL-L106FM

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Mediu ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Medium, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

ProWorks - 00075289112140 Catalog Number : GL-L106FL

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Large ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Natural, 5 mil, Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

ProWorks - 00075289112157 Catalog Number : GL-L106FX

Device Description : ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Black, 5 mil, X-Large ProWorks® Disposable Latex Exam Grade Gloves, Powder Free, Black, 5 mil, X-Large, 100/bx, 10 bxs/cs

Device Class : 1

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

ProWorks - 00075289122323 Catalog Number : GL-N106FS

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 mil, Small ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 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 - 00075289122330 Catalog Number : GL-N106FM

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 mil, Mediu ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 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 - 00075289122347 Catalog Number : GL-N106FL

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 mil, Large ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 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 - 00075289122354 Catalog Number : GL-N106FX

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 mil, X-Lar ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Blue , 5 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

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