ALPHA PRO TECH 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

Accessory, Surgical Apparel (LYU) (4) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (2) Mask, Surgical (FXX) (1)

Premarket Exempt

Yes No

Clear

Critical Cover - 10817583023305 Catalog Number : 2808

Device Description : 1/2 Face Shield, Clear, 7 Mil w/Comfort Headband

Device Class :

Duns Number: 003687733

Premarket Exempt : No

Product Code : HOY

Prescription Use : No

Device Count : 25

Critical Cover - 10817583023312 Catalog Number : 1807

Device Description : Full Face Shield, anti-fog, foam strip, attached comfort headband with snaps

Device Class :

Duns Number: 003687733

Premarket Exempt : No

Product Code : HOY

Prescription Use : No

Device Count : 25

Critical Cover - 10817583023329 Catalog Number : 9400 Veil

Device Description : Face Veil, White, with Comfort Band, 12"X15"

Device Class :

Duns Number: 003687733

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 25

Critical Cover - 10817583023336 Catalog Number : CV-74032-5

Device Description : Coverall, AlphaGuard, White, Inset Sleeve, Zip Close,Tapered Collar, Elastic Wri Coverall, AlphaGuard, White, Inset Sleeve, Zip Close,Tapered Collar, Elastic Wrist, Ankle & Back,2XL

Device Class :

Duns Number: 003687733

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 25

Critical Cover - 10817583023343 Catalog Number : LC-31662-4

Device Description : Lab Coat, AlphaGuard, Blue, Tapered Collar, Knit Wrist, Zip Close, 3 Pockets, XL

Device Class :

Duns Number: 003687733

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 15

Critical Cover - 10817583023350 Catalog Number : LC-31662-6

Device Description : Lab Coat, AlphaGuard, Blue, Tapered Collar, Knit Wrist, Zip Close, 3 Pockets, 3XL

Device Class :

Duns Number: 003687733

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 15

Critical Cover - 10817583023367 Catalog Number : CV-J4002-6

Device Description : Coverall, ComforTech, White, Inset Sleeve, Zip Close, Tapered Collar, Tapered Wr Coverall, ComforTech, White, Inset Sleeve, Zip Close, Tapered Collar, Tapered Wrist and Ankle, 3XL

Device Class :

Duns Number: 003687733

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 25

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