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) (8) Polymer Patient Examination Glove (LZA) (8)

Premarket Exempt

No Yes

Clear

Cirrus - 20810007661005 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 : LZC, LZA

Prescription Use : No

Device Count : 10

Cirrus - 20810007661012 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 : LZC, LZA

Prescription Use : No

Device Count : 10

Cirrus - 20810007661029 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 : LZC, LZA

Prescription Use : No

Device Count : 10

Scion - 20857122007349 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 : LZC, LZA

Prescription Use : No

Device Count : 10

Scion - 20857122007356 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 : 10

Scion - 20857122007363 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 : 10

Scion - 20857122007370 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 : 10

Scion - 20857122007387 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 : 10

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