TRANZONIC ACQUISITION CORP.

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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

Clear

ProWorks - 00075289222269 Catalog Number : GL-N133FXXL

Device Description : ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, ProWorks® Polar Nite® Disposable Nitrile Exam Grade Gloves, Powder Free, White, 3 mil, XX-Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289222825 Catalog Number : GL-N115FS

Device Description : ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Small, 100/ ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Small, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289222832 Catalog Number : GL-N115FM

Device Description : ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Medium, 100 ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Medium, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289222849 Catalog Number : GL-N115FL

Device Description : ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Large, 100/ ProWorks® Disposable Nitrile Exam Gloves, Powder Free, Black, 3 mil, Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

ProWorks - 00075289222856 Catalog Number : GL-N115FX

Device Description : ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 3 mil, X-Lar ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 3 mil, X-Large, 100/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Hero - 00653195430055 Catalog Number : HER005

Device Description : HERO® Disposable Latex Exam Gloves, Powder Free, Blue, 14 mil, Medium, 50/bx, 10 bxs/cs

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

Hand Armor - 00787081126828 Catalog Number : GDNPF105S

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100-SMALL

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Hand Armor - 00787081126835 Catalog Number : GDNPF105M

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100-MEDIUM

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Hand Armor - 00787081126842 Catalog Number : GDNPF105L

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100- LARGE

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Hand Armor - 00787081126859 Catalog Number : GDNPF105X

Device Description : NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100-EX-LARGE

Device Class :

Duns Number: 090125555

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

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