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

Polymer Patient Examination Glove (LZA) (10)

Premarket Exempt

No Yes

Clear

PrimaPro - 00850022371202 Catalog Number :

Device Description : PrimaPro Endurance Black Nitrile Powder Free Examination Glove Small, 100 Gloves PrimaPro Endurance Black 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

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371219 Catalog Number :

Device Description : PrimaPro Endurance Black Nitrile Powder Free Examination Glove Medium, 100 Glove PrimaPro Endurance Black 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

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371226 Catalog Number :

Device Description : PrimaPro Endurance Black Nitrile Powder Free Examination Glove Large, 100 Gloves PrimaPro Endurance Black 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

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371233 Catalog Number :

Device Description : PrimaPro Endurance Black Nitrile Powder Free Examination Glove X-Large, 100 Glov PrimaPro Endurance Black 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

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371240 Catalog Number :

Device Description : PrimaPro Endurance Black Nitrile Powder Free Examination Glove XX-Large, 90 Glov PrimaPro Endurance Black Nitrile Powder Free Examination Glove XX-Large, 90 Gloves/Box, 10 Box/Case, 900 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 90

PrimaPro - 00850022371257 Catalog Number :

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

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371264 Catalog Number :

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

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371271 Catalog Number :

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

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371288 Catalog Number :

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

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

PrimaPro - 00850022371295 Catalog Number :

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

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

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