SEMPERMED USA, INC.

Address:13900 49TH STREET NORTH,CLEARWATER,FL,33762,US

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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

Fentanyl And Other Opioid Protection Glove (QDO) (6) Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs (OPJ) (4) Patient Examination Glove, Specialty (LZC) (2) Polymer Patient Examination Glove (LZA) (2)

Premarket Exempt

Clear

SemperSure Black Nitrile Exam Glove - 00841277106992 Catalog Number : SUNB105

Device Description : SemperSure Black Nitrile Exam Glove, size XL

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : LZA, LZC, QDO

Prescription Use : No

Device Count : 100

SemperShield EC Nitrile Exam Glove - 00841277107050 Catalog Number : SSEC102

Device Description : SemperShield EC Nitrile Exam Glove, size S

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : OPJ, QDO

Prescription Use : No

Device Count : 100

SemperShield EC Nitrile Exam Glove - 00841277107067 Catalog Number : SSEC103

Device Description : SemperShield EC Nitrile Exam Glove, size M

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : OPJ, QDO

Prescription Use : No

Device Count : 100

SemperShield EC Nitrile Exam Glove - 00841277107074 Catalog Number : SSEC104

Device Description : SemperShield EC Nitrile Exam Glove, size L

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : OPJ, QDO

Prescription Use : No

Device Count : 100

SemperShield EC Nitrile Exam Glove - 00841277107081 Catalog Number : SSEC105

Device Description : SemperShield EC Nitrile Exam Glove, size XL

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : OPJ, QDO

Prescription Use : No

Device Count : 100

SemperSure Black Nitrile Exam Glove - 00841277107135 Catalog Number : SPK-SUNB

Device Description : SemperSure Black Nitrile Exam Glove, sample pack

Device Class : 1

Duns Number: 004072158

Premarket Exempt : No

Product Code : LZA, LZC, QDO

Prescription Use : No

Device Count : 6

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