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

Latex Patient Examination Glove (LYY) (4) Vinyl Patient Examination Glove (LYZ) (4) Patient Examination Glove, Specialty (LZC) (2) Polymer Patient Examination Glove (LZA) (2)

Premarket Exempt

No Yes

Clear

PrimaPro - 00850022371301 Catalog Number :

Device Description : PrimaPro GentleGuard Latex Powder Free Examination Glove Small, 100 Gloves/Box, PrimaPro GentleGuard Latex 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 : LYY

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371318 Catalog Number :

Device Description : PrimaPro GentleGuard Latex Powder Free Examination Glove Medium, 100 Gloves/Box, PrimaPro GentleGuard Latex 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 : LYY

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371325 Catalog Number :

Device Description : PrimaPro GentleGuard Latex Powder Free Examination Glove Large, 100 Gloves/Box, PrimaPro GentleGuard Latex 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 : LYY

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371332 Catalog Number :

Device Description : PrimaPro GentleGuard Latex Powder Free Examination Glove X-Large, 100 Gloves/Box PrimaPro GentleGuard Latex 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 : LYY

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371349 Catalog Number :

Device Description : PrimaPro GentleGuard Vinyl Powder Free Examination Glove Medium, 100 Gloves/Box, PrimaPro GentleGuard Vinyl 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 : LYZ

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371356 Catalog Number :

Device Description : PrimaPro GentleGuard Vinyl Powder Free Examination Glove Small, 100 Gloves/Box, PrimaPro GentleGuard Vinyl 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 : LYZ

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371363 Catalog Number :

Device Description : PrimaPro GentleGuard Vinyl Powder Free Examination Glove Large, 100 Gloves/Box, PrimaPro GentleGuard Vinyl 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 : LYZ

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371370 Catalog Number :

Device Description : PrimaPro GentleGuard Vinyl Powder Free Examination Glove X-Large, 100 Gloves/Box PrimaPro GentleGuard Vinyl 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 : LYZ

Prescription Use : No

Device Count : 100

PrimaPro - 00850022371387 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove Sma PrimaPro GentleGuard Comfort Fit Blu 2 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 - 00850022371394 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove Med PrimaPro GentleGuard Comfort Fit Blu 2 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

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