FDA.reportPublic FDA data

Disposable Sterilized Latex Surgical Gloves

Primary DI
16972267280130
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 pair Middle box package quantity: 50 pairs Outer 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
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421353735
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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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