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) (10) Polymer Patient Examination Glove (LZA) (10)

Premarket Exempt

No Yes

Clear

Cirrus - 00810007661018 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 - 00810007661025 Catalog Number :

Device Description : Non Sterile, Powder Free Nitrile Examination Gloves, XL, Blue Colored, Tested fo Non Sterile, Powder Free Nitrile 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

Scion - 00857122007345 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 : 1

Scion - 00857122007352 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 : 1

Scion - 00857122007369 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 : 1

Scion - 00857122007376 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 : 1

Scion - 00857122007383 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 : 1

Cirrus - 00857122007444 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 : LZC, LZA

Prescription Use : No

Device Count : 1

Cirrus - 00857122007451 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 : 1

Cirrus - 00857122007468 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 : 1

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