FDA.reportPublic FDA data

Disposable Sterilized Latex Surgical Gloves

Primary DI
06972267280133
Brand
Disposable Sterilized Latex Surgical Gloves
Company
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Model
8
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
16972267280130PackageGS150In Commercial Distribution
26972267280137PackageGS1400In Commercial Distribution
06972267280133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697226728013016972267280130
2697226728013726972267280137
06972267280133069722672801336972267280133

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex surgical glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

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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