MAZZA HEALTHCARE LLC

Address:2101 Waukegan Rd - Suite 208,Bannockburn,IL,60015,US

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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) (3) Polymer Patient Examination Glove (LZA) (3) Cover, Shoe, Operating-Room (FXP) (3) Fentanyl And Other Opioid Protection Glove (QDO) (2) Non-Surgical Isolation Gown (OEA) (2) Gown, Examination (FME) (1) Cap, Surgical (FYF) (1)

Premarket Exempt

No Yes

Clear

MH - 00850018327541 Catalog Number :

Device Description : Nitrile Examination Gloves, 3.2 g, Low Dermatitis, Chemo Rated, Latex-Free, Powd Nitrile Examination Gloves, 3.2 g, Low Dermatitis, Chemo Rated, Latex-Free, Powder-Free, Non-Sterile, Small, 250/box

Device Class :

Duns Number: 830069063

Premarket Exempt : No

Product Code : LZA, LZC, QDO

Prescription Use : No

Device Count : 250

MH - 00850018327558 Catalog Number :

Device Class :

Duns Number: 830069063

Premarket Exempt : No

Product Code : LZA, LZC, QDO

Prescription Use : No

Device Count : 100

MH - 00850018327671 Catalog Number :

Device Description : 24” Bouffant Cap, Blue, SBPP, Latex Free

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : FYF

Prescription Use : No

Device Count : 100

MH - 00850018327688 Catalog Number :

Device Description : Shoe Cover, Blue, SBPP, Non-conductive, Non-Skid, Universal

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

MH - 00850018327695 Catalog Number :

Device Description : Shoe Cover, Blue, SBPP, Non-conductive, Non-Skid, X-Large

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 100

MH - 00850018327701 Catalog Number :

Device Description : Cover Gown, SBPP, Yellow, X-Large, Elastic Cuff, Neck and Waist Ties, Latex Free

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 10

MH - 00850018327718 Catalog Number :

Device Description : Isolation Gown, SMS AAMI Level 2, Yellow, Large, Elastic Cuff, Tie Waist, Neck T Isolation Gown, SMS AAMI Level 2, Yellow, Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Free

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

MH - 00850018327725 Catalog Number :

Device Description : Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Free

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

MH - 00850018327749 Catalog Number :

Device Description : Nitrile Examination Gloves, 3.5g, Chemo Rated, Latex-Free, Powder-Free, Non-Ster Nitrile Examination Gloves, 3.5g, Chemo Rated, Latex-Free, Powder-Free, Non-Sterile, Extra Small

Device Class :

Duns Number: 830069063

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

MH - 00850018327855 Catalog Number :

Device Description : Boot Covers, Universal, Blue, Non-skid, Latex free

Device Class :

Duns Number: 830069063

Premarket Exempt : Yes

Product Code : FXP

Prescription Use : No

Device Count : 50

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