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

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

Premarket Exempt

No Yes

Clear

HandPro 400 - 10857122007984 Catalog Number :

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

Device Class :

Duns Number: 026777252

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 4

Cirrus - 20810007660008 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 : 10

RoyalTouch - 20810007660138 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 : LZA

Prescription Use : No

Device Count : 10

RoyalTouch - 20810007660145 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 : LZA

Prescription Use : No

Device Count : 10

RoyalTouch - 20810007660152 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 : LZA

Prescription Use : No

Device Count : 10

RoyalTouch - 20810007660169 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 : LZA

Prescription Use : No

Device Count : 10

RoyalTouch - 20810007660176 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 : LZA

Prescription Use : No

Device Count : 10

AirSoft - 20810007660237 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 : LZA

Prescription Use : No

Device Count : 10

AirSoft - 20810007660244 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 : LZA

Prescription Use : No

Device Count : 10

AirSoft - 20810007660251 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 : LZA

Prescription Use : No

Device Count : 10

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