PHU TUONG GARMENT COMPANY LIMITED

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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

Non-Surgical Isolation Gown (OEA) (2) Accessory, Surgical Apparel (LYU) (1) Face Mask (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance (QKR) (1) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (1)

Premarket Exempt

Yes

Clear

PT - 18938533047027 Catalog Number :

Device Description : An isolation gown is made of fabric material, either non-woven or woven

Device Class : 1

Duns Number: 556034954

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

PT - 18938533047041 Catalog Number :

Device Description : An isolation gown is made of fabric material, either non-woven or woven

Device Class : 1

Duns Number: 556034954

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

PT - 18938533047065 Catalog Number :

Device Description : Protective Goggles help to provide eye protection in a variety of applications

Device Class : 1

Duns Number: 556034954

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

PT - 28938533047055 Catalog Number :

Device Description : Face mask is made of fabric material, either non-woven or woven

Device Class :

Duns Number: 556034954

Premarket Exempt : Yes

Product Code : QKR

Prescription Use : No

Device Count : 50

PT - 28938533047093 Catalog Number :

Device Description : A Head Cover is made of fabric material, either non-woven or woven

Device Class : 1

Duns Number: 556034954

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 100

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