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

Disinfectant, medical devices (LRJ) (4) Latex patient examination glove (LYY) (2) CAP, SURGICAL (FYF) (1) GOWN, ISOLATION, SURGICAL (FYC) (1) PACK, HOT OR COLD, DISPOSABLE (IMD) (1) Tape and bandage, adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

Hopkins Medical Products® - 00817643022241 Catalog Number : 615350

Device Description : Micropore Tape 1 inch Kit/EA

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022258 Catalog Number : 620067

Device Description : Instant Heat Pack

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022265 Catalog Number : 690235

Device Description : Personal Protection Gown with Thumb Loop

Device Class : 2

Duns Number: 003080678

Premarket Exempt : No

Product Code : FYC

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022272 Catalog Number : 690604

Device Description : Bouffant Cap Each

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : FYF

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022289 Catalog Number : 691090

Device Description : CaviWipes 6” x 6.75” 220 Wipes/Canister

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022296 Catalog Number : 691101

Device Description : CaviWipes 6” x 6.75” 160 Wipes/Canister

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022302 Catalog Number : 691150

Device Description : CaviWipesXL 10” x 12” 66 Wipes/Canister

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022319 Catalog Number : 691155

Device Description : CaviWipesXL 10” x 12” 50 Individual Packets/Box

Device Class : 1

Duns Number: 003080678

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022326 Catalog Number : 692314-LRG

Device Description : Code Blue Latex Gloves Large 50/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 1

Hopkins Medical Products® - 00817643022333 Catalog Number : 692314-SMA

Device Description : Code Blue Latex Gloves Small 50/PK

Device Class : 1

Duns Number: 003080678

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 1

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