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

Mask, Surgical (FXX) (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 - 00850022371400 Catalog Number :

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

PrimaPro - 00850022371417 Catalog Number :

Device Description : PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove X-L PrimaPro GentleGuard Comfort Fit Blu 2 Nitrile Powder Free Examination Glove X-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

PrimaPro - 00850022371424 Catalog Number :

Device Description : PrimaPro GentleGuard Synthetic Ivory Powder Free Examination Glove Small, 100 Gl PrimaPro GentleGuard Synthetic Ivory 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 - 00850022371431 Catalog Number :

Device Description : PrimaPro GentleGuard Synthetic Ivory Powder Free Examination Glove Medium, 100 G PrimaPro GentleGuard Synthetic Ivory 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 - 00850022371448 Catalog Number :

Device Description : PrimaPro GentleGuard Synthetic Ivory Powder Free Examination Glove Large, 100 Gl PrimaPro GentleGuard Synthetic Ivory 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 - 00850022371455 Catalog Number :

Device Description : PrimaPro GentleGuard Synthetic Ivory Powder Free Examination Glove X-Large, 100 PrimaPro GentleGuard Synthetic Ivory 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 - 00850022371479 Catalog Number :

Device Description : PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex F PrimaPro GentleWare ASTM Level 2 Face Mask, White, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

PrimaPro - 00850022371486 Catalog Number :

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

PrimaPro - 00850022371493 Catalog Number :

Device Description : Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex F Prima Pro GentleWare ASTM Level 2 Face Mask, Blue, 3 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

PrimaPro - 00850022371509 Catalog Number :

Device Description : PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Fr PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use

Device Class :

Duns Number: 089569581

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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