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

Cirrus - 10810007661022 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 : 170

Scion - 10857122007342 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 : 300

Scion - 10857122007359 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 : 300

Scion - 10857122007366 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 : 300

Scion - 10857122007373 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 : 300

Scion - 10857122007380 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 : 250

HandPro 400 - 10857122007946 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 4/PK, XS, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 4

HandPro 400 - 10857122007953 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 4/PK, S, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 4

HandPro 400 - 10857122007960 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 4/PK, M, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 4

HandPro 400 - 10857122007977 Catalog Number :

Device Description : HandPro Latex Exam Powder Free Gloves 4/PK, L, Sample Pack

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 4

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