Product Code: KGX FDA class 1 21 CFR 880.5240

Tape And Bandage, Adhesive

General Hospital

Adhesive Tape and Bandage is a wound care and dressing product consisting of an absorbent pad or fabric strip coated with a pressure-sensitive adhesive, used in general hospital settings to secure dressings, support bandages, or protect minor wounds during healing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGX, regulated under 21 CFR 880.5240, within the General Hospital medical specialty.

510(k)s
184
FEI Numbers
934
Registration Numbers
934
Unique Applicants
106
Years Active
23

Basic Information

Product Code
KGX
Device Class
FDA class 1
Regulation Number
880.5240
Medical Specialty
General Hospital
Review Panel
SU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 184 510(k) clearances via K numbers.

K Number Device Name
K001240 SERAGARD INJECTION PATCH
K983368 CARE BAND ANTIBACTERIAL BANDAGES
K972914 SYVEK PATCH
K943314 ADHESIVE BANDAGES WITH OTC DRUG
K952606 TARGETT PATCH
K954007 PARALLEL
K944587 DERMIVIEW HYPOALLERGENIC CLEAR TAPE
K944588 STERILE PLASTIC DRESSING
K941788 BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP
K940536 BAND-AID(TM) BRAND ADHESIVE BANDAGE
K940798 SHIPPERT PRESSURE BANDAGE
K941389 EMPI TAPE PATCHES
K942383 DERMIVIEW CLEAR TAPE
K940378 COVERLET ADHESIVE DRESSING
K941499 KIT PAK DRESSING CHANGE TRAY
K941943 SURGICAL ADHESIVE TAPE
K941379 ACE SPORTS TAPE
K935948 CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
K932457 SPYROGEL WOUND DRESSING
K935725 EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K930457 MEDIMAC BANDAGE
K932422 3M TEGADERM HP TRANSPARENT DRESSING
K932743 MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
K931886 TISSUE ISOLATION AND RETRIEVAL BAG
K924192 I.V. START KIT (AHC-50-54954
K922441 SURESEAL BANDAGE
K932602 ADHESIVE BANDAGES
K924794 TRANSPARENT ADHESIVE DRESSING
K923319 SHAWNEE PRODUCT KIT IV
K923235 BIOCLUSIVE MVP TRANSPARENT DRESSING
K925384 ISOPORE(TM) TAPE, MODIFICATION
K926264 MEDICOTEST SKIN FIX
K923662 INGROWN TOENAIL PAD
K921761 SHAWNEE PRODUCTS KIT II
K923358 LC STRIP
K922228 2ND SKIN STERILE ADHESIVE STRIP
K923400 DERMCO A-I
K922897 STRAPPAL
K922959 ISOPORE TAPE
K923404 LUEKOFLEX SURGICAL TAPE
K923300 DEROYAL EYE DRESSING
K920675 DUODERM SUSTAINED COMPRESSION BANDAGE
K921760 TRICOPLAST
K921759 ACRYLASTIC
K914733 TTL MEDICATED DRESSING
K915446 STRETCH WRAP
K915358 PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K920182 MARION WINDOW
K915057 CANN-HOLD
K914597 SURGICAL MICROPOROUS TAPE (MICROCEL)
K914596 SURGICAL CLOTH TAPE (HEALRITE)
K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K915565 IMMOBILE
K914245 DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
K914912 PROMEON 63B SURGICAL TAPE
K912623 MEDICAL TAPE
K912160 BUTTERFLY DRESSING
K912518 CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K912550 DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912520 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K911682 AIRSTRIP FIRST AID & POST-OP DRESSING
K910657 QUALTEX ISLAND DRESSING
K895920 VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS
K910678 TRO-GARD
K910436 ELASTIC ADHESIVE BANDAGE
K904904 MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
K904445 OMIBAND
K905022 AQUA-GARD WATERPROOF WOUND PATCH
K903823 SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
K904500 ELASTOPLAST
K896068 TIPSTOP(TM)
K901777 3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901845 TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901879 INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K902010 VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K900447 DUODERM* ADHESIVE COMPRESSION BANDAGE
K896455 VITACHOICE WOUND DRESSING
K896891 LEUKOSILK(TM) SURGICAL TAPE
K896733 VACCON
K896358 VARI/MOIST WOUND DRESSING
K895884 BANDAGE REMOVAL STRIP
K895408 OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM)
K894367 LEUKOSPORT(TM) ADHESIVE TAPE
K892450 MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K895353 OPSITE I.V. 3000
K894916 COMFEEL TRANSPARENT DRESSING
K895376 ACTIDERM (TM) DERMATOLOGICAL PATCH
K893569 QUICK CHANGE MONTGOMERY STRAP
K894274 EXUSORB TRANSPARENT DRESSING
K890917 PHOENIX DRAPES WITH MICROBAN
K894147 VISULIN TRANSPARENT ADHESIVE DRESSING
K893900 PRIMAPORE I.V.
K885205 AQUADERM
K883660 DERMASTRIP
K883983 SANIFIX
K884108 MACROPORE MEDICAL/SURGICAL PAPER TAPE
K881397 SANAPLAST
K881509 LEUKOPOR(TM) SURGICAL TAPE
K880207 EXPANDOVER ELASTIC BANDAGE
K880964 POLYDERM PEC(TM), POROUS ELASTIC COVER
K872975 LIGHTPLAST(TM)
K872594 ANDOVER MOLESKIN
K872593 ANDOVER ADHESIVE TAPE, SURGICAL
K870900 THE GRIPPER SEAL(TM)
K870093 MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM
K870092 MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
K870021 MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE
K870091 IV SECUREMENT DEVICE USING PCCE THERMO. FILM
K870090 IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
K870020 IV SECUREMENT DEVICE
K864076 HERCON ANTISEPTIC TRANSPARENT DRESSING
K864160 LEUKOPLAST(R) POROUS AND SPORT TAPE
K863753 FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
K860804 MEDICAL ADHESIVE TAPE
K854006 PLASTELAST AND/OR ELASTOPLASTE
K853820 SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853647 NITTO SURGICAL PAPER TAPE ST-310
K853646 NITTO SURGICAL NON-WOVEN TAPE ST-320
K853645 NITTO SURGICAL CLOTH TAPE ST-330
K853644 NITTO SURGICAL PLASTIC TAPE ST-356
K852408 EXTRA LARGE ADHESIVE STRIPS
K852462 TRICOT ADHESIVE BANDAGE
K850529 SHEER ADHESIVE BANDAGES, STERILE
K850133 VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K843876 LEUKOFLEX SURGICAL TAPE
K843875 LEUKOSILK
K843874 LEUKOPOR SURGICAL TAPE
K843873 LEUKOFIX R
K844463 DERMIDRESS
K842946 ACU-PATCH
K843587 PETIT BANDS
K842511 BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842301 DISPOSABLE LATEX BANDAGE
K840951 FIRST AID BANDAGE
K840950 ZINC OXIDE TAPE
K840609 SKIN TECH. ISOTEX 86L
K840448 MEDICAL ADHESIVE FOAM TAPE
K840446 MEDICAL TAPE
K840949 CLEAR PLASTIC-HYPOALLERGENIC
K840947 CLOTH-HYPOALLERGENIC
K840447 MICROPOROUS MED. ADHESIVE TAPE
K841899 FIRST RESPONSE EMERG. MEDICAL SYS BONES
K841897 FIRST RESPONSE EMERG. MEDICAL SYSTEM
K833688 SUTURE REMOVAL KITS STERILE
K833954 MELOLITE
K833916 HYPAFIX DRESSING RETENTION SHEET
K833731 BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833590 DRESS, SURGICAL ADHESIVE
K833120 ONE TIME COMPOUND BENZOIN TINCTURE-
K832544 SYSTENET
K822824 ADHESIVE TAPE/FIRST-BAND
K813265 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K823076 SATOBAN FIRST AID TAPE
K821490 SILKAFIX ADHESIVE PLASTER
K821257 SELOFIX
K820872 CURITY SHETHOSCOPE SECURING PADS
K820018 COMFEEL PROTECTIVE SHEET
K813364 MEDICAL TAPE (MULTIPLE)
K813361 ADHESIVE STRIP(MULTIPLE)
K813421 NON-ADHER PADS
K813124 ETHICON* SKIN CLOSURE TAPE
K811291 TEGADERM TRANSPARENT DRESSING
K810896 VENTI-GARD JR.
K810623 BAND-AID KITCHEN ASSORTMENT
K810580 SCOTCH BRAND ADHESIVE TAPE
K810126 CURITY CURAD BANDAGES
K810053 JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K803153 ELASTIC ADHESIVE BANDAGES
K802795 ORTHOPEDIC PADDING
K802752 POROUS, BREATHING TAPE W/RELEASE LINER
K802764 PLASTIC ADHESIVE BANDAGE
K802242 3M HI-STRENGTH MED. TAPE #1534
K802073 MUELLER STRETCH M TAPE
K801794 ELASTIC ADHESIVE BANDAGES(STERILE)
K800907 TOMAC WET DRESSING WARMER
K792666 LEUKOPOR
K792103 HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K792102 HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K791886 I.V. CARE KIT
K791885 I.V. START SET
K791288 YELLOW ALERT SYSTEM
K770362 TAPE, DERMICEL, CLOTH
K761336 BAND-AID BRAND PLASTIC BANDAGES
K761335 BAND-AID BRAND SHEER BANDAGES

FEI Numbers

This FDA classification entry is associated with 934 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 934 registration numbers. Click on an entry to view related FDA registrations.