Examination gloves – Type C (Nitrile gloves)

GUDID 26972267280182

Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 1000PCS

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID26972267280182
NIH Device Record Keye42a417e-5d7a-4373-8d76-c28e2873a323
Commercial Distribution StatusIn Commercial Distribution
Brand NameExamination gloves – Type C (Nitrile gloves)
Version Model NumberXL
Company DUNS421353735
Company NameJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106972267280188 [Unit of Use]
GS116972267280185 [Primary]
GS126972267280182 [Package]
Contains: 16972267280185
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-02
Device Publish Date2022-07-25

On-Brand Devices [Examination gloves – Type C (Nitrile gloves)]

26972267280182Powder-free textured; The packages of proposed device including middle box package and outer car
26972267280175Powder-free textured; The packages of proposed device including middle box package and outer car
26972267280168Powder-free textured; The packages of proposed device including middle box package and outer ca
26972267280151Powder-free textured; The packages of proposed device including middle box package and outer ca

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