HOPKINS UNIFORM COMPANY

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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) (4) Latex patient examination glove (LYY) (3) SYRINGE, IRRIGATING (NON DENTAL) (KYZ) (1) Speculum, vaginal, nonmetal (HIB) (1) TOURNIQUET, NONPNEUMATIC (GAX) (1)

Premarket Exempt

Yes No

Clear

Hopkins Medical Products® - 00817643021831 Catalog Number : 542434

Device Description : Welch Allyn KleenSpec 4.25mm Disposable Ear Specula PK850

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : HIB

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021848 Catalog Number : 549360

Device Description : Welch Allyn Ear Wash System Eartips PK25

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : KYZ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021862 Catalog Number : 554901

Device Description : Disposable Latex Free Tourniquet 10/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : GAX

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021879 Catalog Number : 570675-LRG

Device Description : Pink Vinyl Powder Free Gloves- Large 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021886 Catalog Number : 570675-MED

Device Description : Pink Vinyl Powder Free Gloves- Medium 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021893 Catalog Number : 570675-SMA

Device Description : Pink Vinyl Powder Free Gloves Small 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021909 Catalog Number : 570675-XLRG

Device Description : Pink Vinyl Powder Free Gloves X-Large 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021916 Catalog Number : 570849-MED

Device Description : Powder Free Latex Free Gloves Medium, each

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021923 Catalog Number : 570850-LRG

Device Description : Powder Free Latex free Gloves Large 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643021930 Catalog Number : 570850-MED

Device Description : Powder Free Latex Free Gloves Medium 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LYY

Prescription Use : No

Device Count : 1

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