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) (10) Patient Examination Glove, Specialty (LZC) (1)

Premarket Exempt

No Yes

Clear

Cirrus - 00810007660004 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 : LZA, LZC

Prescription Use : No

Device Count : 1

RoyalTouch - 00810007660134 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 : 1

RoyalTouch - 00810007660141 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 : 1

RoyalTouch - 00810007660158 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 : 1

RoyalTouch - 00810007660165 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 : 1

RoyalTouch - 00810007660172 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 : 1

AirSoft - 00810007660233 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 : 1

AirSoft - 00810007660240 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 : 1

AirSoft - 00810007660257 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 : 1

AirSoft - 00810007660264 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 : 1

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