HOURGLASS 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

Polymer Patient Examination Glove (LZA) (10) Patient Examination Glove, Specialty (LZC) (9)

Premarket Exempt

No Yes

Clear

Cirrus - 00857122007475 Catalog Number :

Device Description : Non Sterile, Powder Free Examination Gloves, L, Blue Colored, Tested for Use wit Non Sterile, Powder Free Examination Gloves, L, Blue Colored, Tested for Use with Chemotherapy Drugs.

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZA, LZC

Prescription Use : No

Device Count : 1

Cirrus - 00857122007482 Catalog Number :

Device Description : Non Sterile, Powder Free Examination Gloves, XL, Blue Colored, Tested for Use wi Non Sterile, Powder Free Examination Gloves, XL, Blue Colored, Tested for Use with Chemotherapy Drugs.

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZA, LZC

Prescription Use : No

Device Count : 1

Cirrus - 10810007660001 Catalog Number :

Device Description : Non Sterile, Powder Free Examination Gloves, XS, Blue Colored, Tested for Use wi Non Sterile, Powder Free Examination Gloves, XS, Blue Colored, Tested for Use with Chemotherapy Drugs.

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

Fortis - 10810007660018 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves, 100/BX, XS, Black, Tested for Use with C Fortis Nitrile Exam Powder Free Gloves, 100/BX, XS, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

Fortis - 10810007660025 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 100/BX, S, Black, Tested for Use with Che Fortis Nitrile Exam Powder Free Gloves 100/BX, S, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

Fortis - 10810007660032 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 100/BX, M, Black, Tested for Use with Che Fortis Nitrile Exam Powder Free Gloves 100/BX, M, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

Fortis - 10810007660049 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 100/BX, L, Black, Tested for Use with Che Fortis Nitrile Exam Powder Free Gloves 100/BX, L, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

Fortis - 10810007660056 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 100/BX, XL, Black, Tested for Use with Ch Fortis Nitrile Exam Powder Free Gloves 100/BX, XL, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

Fortis - 10810007660063 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 90/BX, XXL, Black, Tested for Use with Ch Fortis Nitrile Exam Powder Free Gloves 90/BX, XXL, Black, Tested for Use with Chemotherapy Drugs

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 90

RoyalTouch - 10810007660131 Catalog Number :

Device Description : Nitrile Powder Free Examination Gloves, XS, Tested for Use with Chemotherapy Drugs.

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 300

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