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

Patient Examination Glove, Specialty (LZC) (9) Polymer Patient Examination Glove (LZA) (9) Latex Patient Examination Glove (LYY) (1)

Premarket Exempt

No Yes

Clear

HandPro 400 - 10810007660513 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 80/BX , XL

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 80

Fortis - 10810007660575 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves, 6/PK, XS, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Fortis - 10810007660582 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 6/PK, S, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Fortis - 10810007660599 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 6/PK, M, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Fortis - 10810007660605 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 6/PK, L, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Fortis - 10810007660612 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 6/PK, XL, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Fortis - 10810007660629 Catalog Number :

Device Description : Fortis Nitrile Exam Powder Free Gloves 6/PK, XXL, Black, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 6

Cirrus - 10810007660995 Catalog Number :

Device Description : Non Sterile, Powder Free Examination Gloves, S, Blue Colored, Tested for Use wit Non Sterile, Powder Free Examination Gloves, S, 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

Cirrus - 10810007661008 Catalog Number :

Device Description : Non Sterile, Powder Free Examination Gloves, M, Blue Colored, Tested for Use wit Non Sterile, Powder Free Examination Gloves, M, 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

Cirrus - 10810007661015 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 : 200

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