Xuchang Zhengde Environstar Medical Products Co., Ltd.

Address:No.3 Weilai Road, Industry Cluster District, Yanling County,Xuchang Henan,CN

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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) (6) Gown, Surgical (FYA) (4)

Premarket Exempt

No Yes

Clear

ZD Isolation Gown-CP - 06971004782862 Catalog Number :

Device Description : Isolation Gown, L, 10 pieces/bag, 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ZD Isolation Gown-CP - 06971004782886 Catalog Number :

Device Description : Isolation Gown, XL, 10 pieces/bag, 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ZD Isolation Gown-C - 06971004783104 Catalog Number :

Device Description : Isolation Gown, L, 10 pieces/bag, 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ZD Isolation Gown-C - 06971004783128 Catalog Number :

Device Description : Isolation Gown, XL, 10 pieces/bag, 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Zhende SG-WR - 06971004783265 Catalog Number :

Device Description : Surgical Gown With Reinforcement, M, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton

Device Class :

Duns Number: 421272799

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Zhende SG-WR - 06971004783289 Catalog Number :

Device Description : Surgical Gown With Reinforcement, L, AAMI PB70 Level 3, 1 piece/bag, 28 pieces/carton

Device Class : 2

Duns Number: 421272799

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Zhende SG-WR - 06971004783302 Catalog Number :

Device Description : Surgical Gown With Reinforcement, XL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton

Device Class : 2

Duns Number: 421272799

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Zhende SG-WR - 06971004783326 Catalog Number :

Device Description : Surgical Gown With Reinforcement, XXL, AAMI PB70 Level 3, 1 piece/bag, 26 pieces/carton

Device Class : 2

Duns Number: 421272799

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

ZD Isolation Gown-CP - 06971004784811 Catalog Number :

Device Description : Isolation Gown, L, 10 pieces/bag. 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ZD Isolation Gown-CP - 06971004784835 Catalog Number :

Device Description : Isolation Gown, XL, 10 pieces/bag, 10 bags/case

Device Class : 1

Duns Number: 421272799

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

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