SemperForce Blue Nitrile Exam Glove SPK-BKLF

GUDID 00841277105926

SemperForce Blue Nitrile Exam Glove, sample pack

SEMPERMED USA, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00841277105926
NIH Device Record Key4a72c3a2-dc01-4031-aa65-bed23cdf2655
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemperForce Blue Nitrile Exam Glove
Version Model NumberSPK-BKLF
Catalog NumberSPK-BKLF
Company DUNS004072158
Company NameSEMPERMED USA, INC.
Device Count6
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277105902 [Primary]
GS100841277105926 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

On-Brand Devices [SemperForce Blue Nitrile Exam Glove]

00841277105926SemperForce Blue Nitrile Exam Glove, sample pack
00841277105896SemperForce Blue Nitrile Exam Glove, size XL
00841277105889SemperForce Blue Nitrile Exam Glove, size L
00841277105872SemperForce Blue Nitrile Exam Glove, size M
00841277105865SemperForce Blue Nitrile Exam Glove, size S

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