Agio Group 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) (6) Vinyl Patient Examination Glove (LYZ) (4)

Premarket Exempt

Clear

sunnycare - 10850044355768 Catalog Number : 8605

Device Description : SUNNYCARE brand nitrile examination gloves powder free blue xxlarge size 100pcs SUNNYCARE brand nitrile examination gloves powder free blue xxlarge size 100pcs/box 10boxes/case 5 mil chemo rated

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355775 Catalog Number : 8901

Device Description : SUNNYCARE brand nitrile examination gloves powder free black small size 100 pc SUNNYCARE brand nitrile examination gloves powder free black small size 100 pcs/box 10boxes/case 5 mil chemo rated

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355782 Catalog Number : 8902

Device Description : SUNNYCARE brand nitrile examination gloves powder free black medium size 100 pc SUNNYCARE brand nitrile examination gloves powder free black medium size 100 pcs/box 10 boxes/case

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355799 Catalog Number : 8903

Device Description : SUNNYCARE brand nitrile examination gloves powder free black large size 100pc SUNNYCARE brand nitrile examination gloves powder free black large size 100pcs/box,10boxes/case 5 mil

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355805 Catalog Number : 8904

Device Description : SUNNYCARE brand nitrile examination gloves powder free black xlarge size 100pc SUNNYCARE brand nitrile examination gloves powder free black xlarge size 100pcs/box,10boxes/case 5 mil

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355812 Catalog Number : 8905

Device Description : SUNNYCARE brand nitrile examination gloves powder free black xxlarge size 100pc SUNNYCARE brand nitrile examination gloves powder free black xxlarge size 100pcs/box 10 boxes/case 5 mil

Device Class : 1

Duns Number: 611739033

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

sunnycare - 10850044355829 Catalog Number : 7601

Device Description : SUNNYCARE brand vinyl examination gloves powder free clear 100pcs/box 10 boxe SUNNYCARE brand vinyl examination gloves powder free clear 100pcs/box 10 boxes/case small size

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

sunnycare - 10850044355836 Catalog Number : 7602

Device Description : SUNNYCARE brand vinyl examination gloves powder free clear medium size 100pcs SUNNYCARE brand vinyl examination gloves powder free clear medium size 100pcs/box 10 boxes/case

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

sunnycare - 10850044355843 Catalog Number : 7603

Device Description : SUNNYCARE brand vinyl examination gloves powder free clear 100pcs/box, 10boxes/ SUNNYCARE brand vinyl examination gloves powder free clear 100pcs/box, 10boxes/case large size

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

sunnycare - 10850044355850 Catalog Number : 7604

Device Description : SUNNYCARE brand vinyl examination gloves powder free clear xlarge size 100pcs/bo SUNNYCARE brand vinyl examination gloves powder free clear xlarge size 100pcs/box 10 boxes/case

Device Class :

Duns Number: 611739033

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

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