FDA.reportPublic FDA data

MocareHealth

Primary DI
26971384150880
Brand
MocareHealth
Company
Motex Healthcare(Anhui)Co.,Ltd.
Model
1610/7
Device description
Single-use sterile rubber surgical gloves
Published
2021-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063757000MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVESShanghai Motex Healthcare Co., Ltd.2007-07-27KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36971384150887PackageGS16Not in Commercial Distribution
26971384150880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697138415088736971384150887
2697138415088026971384150880

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
560080502
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26971384150842MocareHealth1610/52021-08-26
26971384150859MocareHealth1610/5.52021-08-26
26971384150866MocareHealth1610/62021-08-26
26971384150873MocareHealth1610/6.52021-08-26
26971384150897MocareHealth1610/7.52021-08-26
26971384150903MocareHealth1610/82021-08-26
26971384150910MocareHealth1610/8.52021-08-26
26971384150927MocareHealth1610/92021-08-26
26971384150934MocareHealth1610/9.52021-08-26
26971384150026MocareHealth7235S2021-08-24
26971384150040MocareHealth7235L2021-08-24
26971384150057MocareHealth7235XL2021-08-24
16971384154829MocareHealth7235-5.5/L2026-04-17
26971384154826MocareHealth7235-5.5/L2026-04-17
36971384154823MocareHealth7235-5.5/L2026-04-17
26971384150019MocareHealth7235XS2020-09-09
16971384153648MocareHealth7521F/52024-08-16
16971384153655MocareHealth7521F/5.52024-08-16
16971384153662MocareHealth7521F/62024-08-16
16971384153679MocareHealth7521F/6.52024-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350064938Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350119621Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350176181Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350407926Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350581305Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350696177Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350861582Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350974121Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350999124Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
10809160542125HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
00755676002369mvetADI MedicalKGO2026-10-26
00755676002376mvetADI MedicalKGO2026-10-26
00755676002413mvetADI MedicalKGO2026-10-26
00755676002437mvetADI MedicalKGO2026-10-26
00755676002451mvetADI MedicalKGO2026-10-26
00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
10809160538968HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-24
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03