A PLUS INTERNATIONAL INC.

Address:5138 EUCALYPTUS AVE.,CHINO,CA,91710,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

Accessory, Surgical Apparel (LYU) (6) Mask, Surgical (FXX) (3) Non-Surgical Isolation Gown (OEA) (1)

Premarket Exempt

No Yes

Clear

SURGIPLUS - 00683534060520 Catalog Number : 68-6201-B

Device Description : PE FILM GOWN A garment made of natural and/or synthetic materials intended to be PE FILM GOWN A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Device Class :

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

A Plus - 00683534080016 Catalog Number : 68-601W-L

Device Description : COVERALL, E/W&A, COLLAR;WHITE, L

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

A Plus - 00683534080023 Catalog Number : 68-601W-M

Device Description : COVERALL, E/W&A, COLLAR;WHITE, M

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

A Plus - 00683534080030 Catalog Number : 68-601W-S

Device Description : COVERALL, E/W&A, COLLAR;WHITE, S

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

A Plus - 00683534080047 Catalog Number : 68-601W-X

Device Description : COVERALL, E/W&A, COLLAR;WHITE, XL

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

A Plus - 00683534080054 Catalog Number : 68-601W-Y

Device Description : COVERALL, E/W&A, COLLAR;WHITE, XXL

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

A Plus - 00683534080061 Catalog Number : 68-601W-Z

Device Description : COVERALL, E/W&A, COLLAR;WHITE, XXXL

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

SURGIPLUS - 00683534090046 Catalog Number : 68-8600-B

Device Description : PROCEDURE MASKFACE MASK WITH EARLOOPBLUE

Device Class :

Duns Number: 191705904

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

SURGIPLUS - 00683534090077 Catalog Number : 68-8601-G

Device Description : PROCEDURE MASKFACE MASK WITH EARLOOPGreen

Device Class :

Duns Number: 191705904

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

SURGIPLUS - 00683534090091 Catalog Number : 68-8603-G

Device Description : PROCEDURE MASKFACE MASK WITH EARLOOPGreen

Device Class :

Duns Number: 191705904

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

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