GluSeal®

GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.

Registry build 21.09.26
3manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMF
Manufacturer City Province Registered as Device types
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20

Record

Regulatory record for GluSeal®
Listed by Glustich Inc
FDA product code KMF
Device type Bandage, Liquid
Device class Class 1
Regulation 21 CFR 880.5090
510(k) K030574
Record published 2017-04-07
Record revised 2022-01-25 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Packaging Box of 12
Distribution end date 2022-01-24

Catalogue Numbers

Catalogue numbers for GluSeal®
Catalogue number Size Status
GLUSEAL5(C)HV In distribution
GLUSEAL5V In distribution
GLUSEAL(C) In distribution
GLUSEAL(V) In distribution
GLUSEAL5C In distribution
GLUSEAL(C)HV In distribution
GLUSEALPT Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PolyMem Ferris MFG. Corp. 60
3M™ Cavilon™ 3M Company 54
Kendall Cardinal Health 23
Kendall Cardinal Health 200, LLC 15
Curity Cardinal Health 11
Stratis Covidien LP 7
Curity Cardinal Health 200, LLC 6
Tritis Covidien LP 4
GluSeal®90 Glustich Inc 3
Medline Medline Industries, Inc. 3
GluSeal®90 Skinstitch Corp. 2
Medline Industries, Inc. Medline Industries, Inc. 2

Showing 12 of 29. All products under Bandage, Liquid

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer