3A Medical Products Co.,Ltd

Address:YuAn Industrial Park,LIU AN Anhui,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

Gown, Surgical (FYA) (10)

Premarket Exempt

No Yes

Clear

3A MEDICAL - 00850029191001 Catalog Number :

Device Description : Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191018 Catalog Number :

Device Description : Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A Medical - 00850029191025 Catalog Number :

Device Description : Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A Medical - 00850029191032 Catalog Number :

Device Description : Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB7 Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A Medical - 00850029191049 Catalog Number :

Device Description : Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191056 Catalog Number :

Device Description : Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,M Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191063 Catalog Number :

Device Description : Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191070 Catalog Number :

Device Description : Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,M Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191087 Catalog Number :

Device Description : Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

3A MEDICAL - 00850029191094 Catalog Number :

Device Description : Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70 Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407

Device Class : 2

Duns Number: 544515279

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

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