PRIMARY PRODUCTS COMPANY

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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

Patient Examination Glove, Specialty (LZC) (10) Polymer Patient Examination Glove (LZA) (10)

Premarket Exempt

No Yes

Clear

PrimaPro - 00850022371004 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove X-Small, 1 PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371011 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Small, 100 PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371028 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Medium, 10 PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Medium, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371035 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Large, 100 PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371042 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove X-Large, 1 PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371059 Catalog Number :

Device Description : PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove XX-Large, PrimaPro GentleGuard Ultra Blue Nitrile Powder Free Examination Glove XX-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371066 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove X-Small, PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove X-Small, 200 Gloves/Box, 10 Box/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371073 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Small, 20 PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Small, 200 Gloves/Box, 10 Box/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371080 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Medium, 2 PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Medium, 200 Gloves/Box, 10 Box/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371097 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Large, 20 PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove Large, 200 Gloves/Box, 10 Box/Case, 2,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA, LZC

Prescription Use : No

Device Count : 200

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