FDA.reportPublic FDA data

KBMED

Primary DI
10810100050327
Brand
KBMED
Company
KB Medical (group), Inc.
Model
LC30M
Device description
LAB COAT, 30GSM PP, SIZE M
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYEDress, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYEDress, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810100050327PackageGS150In Commercial Distribution
00810100050320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010005032710810100050327
00810100050320008101000503208101000503200810100050320

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105002071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810100051270KBMEDSCB10502025-05-23
00810100051280KBMEDPT101002025-05-23
00810100051273KBMEDSCB10502025-05-23
10810100051287KBMEDPT101002025-05-23
20810100051277KBMEDSCB10502025-05-23
00810100050269KBMEDTT-PPS102025-05-22
00810100050283KBMEDTT-PS12752025-05-22
00810100050306KBMEDCAP-TT12752025-05-22
00810100050313KBMEDLC30S2025-05-22
00810100050320KBMEDLC30M2025-05-22
00810100050337KBMEDLC30L2025-05-22
00810100050344KBMEDLC30XL2025-05-22
00810100050429KBMEDCB1502025-05-22
00810100050511KBMEDCTPS152025-05-22
00810100050528KBMEDCTPP152025-05-22
00810100050535KBMEDCTPP15-C2025-05-22
00810100050542KBMEDTT-PP12752025-05-22
00810100050559KBMEDCAP-TT1275P2025-05-22
00810100050566KBMEDUC90-B2B2025-05-22
00810100050603KBMEDTT-GB12752025-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810100050313KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050320KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050337KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050344KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050310KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050334KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050341KBMEDKB Medical (group), Inc.FYE2025-05-22
10097604601129Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
10097604603345Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604601122Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604603348Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
06970645860113YINGJIAJiangsu Jiawen Medical Supplies Co.,Ltd.FYE2022-10-20
10732224000920Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10732224000944Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000935Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000959Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000928Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000942Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000930Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000954Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10889950134136Crosstex™HU-FRIEDY MFG. CO., LLCFYE2022-03-11
00813360021390ProtexerICP MEDICAL, LLCFYE2022-02-03
10813360021397ProtexerICP MEDICAL, LLCFYE2022-02-03
10653160317609CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFYE2022-01-01
00653160317602CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFYE2022-01-01
10653160217626Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
40653160217627Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
B086105051Protect U Guard CPE Isolation GownPROTECT U GUARD, LLCFYE2021-02-02
06944414040914MED-LINKShenzhen Med-Link Electronics Tech Co.,Ltd.FYE2020-05-07
10603295326359LIFE LINERDEPUY ORTHOPAEDICS, INC.FYE2018-09-24