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) (5) Lancet, blood (FMK) (4) Tape and bandage, adhesive (KGX) (1)

Premarket Exempt

Yes No

Clear

Hopkins Medical Products® - 00817643022043 Catalog Number : 575062-SMA

Device Description : Halyard Purple Nitrile Exam Gloves Small Box 100

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022050 Catalog Number : 579250-LRG

Device Description : Nitrile Gloves, Large 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022067 Catalog Number : 579250-MED

Device Description : Nitrile Gloves, Medium 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022074 Catalog Number : 579250-SMA

Device Description : Nitrile Gloves, Small 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022081 Catalog Number : 579250-XLRG

Device Description : Nitrile Gloves, X-Large 100/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022098 Catalog Number : 592001

Device Description : One-Step + Lancet 1.8mm Green 100/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022104 Catalog Number : 592011

Device Description : OneStep+ Lancet 1.8mm Grey 100/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022111 Catalog Number : 592401

Device Description : OneStep+ Lancet 2.2mm Orange 100/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022128 Catalog Number : 593001

Device Description : OneStep+ Lancet 2.8mm Pink 100/PK

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022135 Catalog Number : 610220

Device Description : Surgical Tape Transparent 2 inchx10yds

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

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