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) (9) Latex Patient Examination Glove (LYY) (1)

Premarket Exempt

No Yes

Clear

Hand Armor - 00787081114368 Catalog Number : GDLPF101XX

Device Description : LATEX HIGH RISK POWDER FREE GLOVES 13 MIL BLUE, 10/50, XXL

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

HandArmor - 00787081122325 Catalog Number : GDNPF101S

Device Description : NITRILE POWDER FREE EXAM GLOVES BLUE, 10/100-SMALL

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122332 Catalog Number : GDNPF101M

Device Description : NITRILE POWDER FREE EXAM GLOVES BLUE, 10/100-MEDIUM

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122349 Catalog Number : GDNPF101L

Device Description : NITRILE POWDER FREE EXAM GLOVES BLUE, 10/100-LARGE

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122356 Catalog Number : GDNPF101X

Device Description : NITRILE POWDER FREE EXAM GLOVES BLUE, 10/100-EX-LARGE

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122363 Catalog Number : GDNPF101XX

Device Description : NITRILE POWDER FREE EXAM GLOVES BLUE, 10/100-XX-LARGE

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122929 Catalog Number : GDNPF102S

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK, 10/100-SMALL

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122936 Catalog Number : GDNPF102M

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK, 10/100-MEDIUM

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122943 Catalog Number : GDNPF102L

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK, 10/100-LARGE

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HandArmor - 00787081122950 Catalog Number : GDNPF102X

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK, 10/100-EX-LARGE

Device Class :

Duns Number: 007900020

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

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