FDA.reportPublic FDA data

Disposable Sterilized Latex Surgical Gloves

Primary DI
06972267280140
Brand
Disposable Sterilized Latex Surgical Gloves
Company
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Model
8.5
Device description
Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package.Immediate package quantity: 1 pairMiddle box package quantity: 50 pairsOuter carton package quantity: 400 pairs
Published
2022-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K211953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211953000Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-05-25KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972267280147PackageGS150In Commercial Distribution
26972267280144PackageGS1400In Commercial Distribution
06972267280140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697226728014716972267280147
2697226728014426972267280144
06972267280140069722672801406972267280140

Regulatory Flags#

DUNS number
421353735
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16972267280314Examination gloves – Type A (Latex gloves)S2022-08-10
16972267280321Examination gloves – Type A (Latex gloves)M2022-08-10
16972267280338Examination gloves – Type A (Latex gloves)L2022-08-10
16972267280352Examination gloves – Type A (Latex gloves)XL2022-08-10
26972267280311Examination gloves – Type A (Latex gloves)S2022-08-10
26972267280328Examination gloves – Type A (Latex gloves)M2022-08-10
26972267280335Examination gloves – Type A (Latex gloves)L2022-08-10
26972267280359Examination gloves – Type A (Latex gloves)XL2022-08-10
16972267280154Examination gloves – Type C (Nitrile gloves)S2022-07-25
16972267280161Examination gloves – Type C (Nitrile gloves)M2022-07-25
16972267280178Examination gloves – Type C (Nitrile gloves)L2022-07-25
16972267280185Examination gloves – Type C (Nitrile gloves)XL2022-07-25
26972267280151Examination gloves – Type C (Nitrile gloves)S2022-07-25
26972267280168Examination gloves – Type C (Nitrile gloves)M2022-07-25
26972267280175Examination gloves – Type C (Nitrile gloves)L2022-07-25
26972267280182Examination gloves – Type C (Nitrile gloves)XL2022-07-25
06972267280003Disposable Sterilized Latex Surgical Gloves62022-07-18
06972267280102Disposable Sterilized Latex Surgical Gloves6.52022-07-18
06972267280119Disposable Sterilized Latex Surgical Gloves72022-07-18
06972267280126Disposable Sterilized Latex Surgical Gloves7.52022-07-18

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Primary DI, Brand, Company table
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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
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07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
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