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) (6) Polymer Patient Examination Glove (LZA) (6) Latex Patient Examination Glove (LYY) (4)

Premarket Exempt

No Yes

Clear

FreeStyle - 10810007660346 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 100

FreeStyle - 10810007660353 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 100

FreeStyle - 10810007660360 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 100

FreeStyle - 10810007660377 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 100

FreeStyle - 10810007660384 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 80

FreeStyle - 10810007660391 Catalog Number :

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

Device Class : 1

Duns Number: 026777252

Premarket Exempt : Yes

Product Code : LZC, LZA

Prescription Use : No

Device Count : 100

HandPro 400 - 10810007660476 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 100/BX , XS

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

HandPro 400 - 10810007660483 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 100/BX , S

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

HandPro 400 - 10810007660490 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 100/BX , M

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

HandPro 400 - 10810007660506 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 100/BX , L

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

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