Tradex International, Inc.

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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

Latex patient examination glove (LYY) (4) Polymer patient examination glove (LZA) (1) Vinyl patient examination glove (LYZ) (1)

Premarket Exempt

Clear

AMBITEX - 00699320107928 Catalog Number : LSM240

Device Description : AMBITEX LATEX EXAM PF SM

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

AMBITEX - 00699320107935 Catalog Number : LMD240

Device Description : AMBITEX LATEX EXAM PF MD

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

AMBITEX - 00699320107942 Catalog Number : LLG240

Device Description : AMBITEX LATEX EXAM PF LG

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

AMBITEX - 00699320107959 Catalog Number : LXL240

Device Description : AMBITEX LATEX EXAM PF XL

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

AMBITEX - 00699320334706 Catalog Number : 33470-4

Device Description : 0

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 50

AMBITEX - 00699320452004 Catalog Number : GDN22024

Device Description : NITRILE EXAM PF 10/12/10 FM

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 10

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