latex edition IC SCLT105

GUDID 00841277109221

Latex Exam Glove, PF size XL

SEMPERMED USA, INC.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00841277109221
NIH Device Record Keyb5ba4c4e-0577-4569-a6c3-ba7978086133
Commercial Distribution Discontinuation2025-01-24
Commercial Distribution StatusNot in Commercial Distribution
Brand Namelatex edition IC
Version Model NumberSCLT105
Catalog NumberSCLT105
Company DUNS004072158
Company NameSEMPERMED USA, INC.
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com
Phone800-366-9545
EmailGlove.Info@SempermedUSA.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277109177 [Primary]
GS100841277109221 [Unit of Use]

FDA Product Code

LYYLatex 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 Date2025-02-03
Device Publish Date2025-01-24

Devices Manufactured by SEMPERMED USA, INC.

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00841277109108 - Xpert2025-02-03 Nitrile Exam Glove, PF size XL
00841277109115 - Xpert2025-02-03 Nitrile Exam Glove, PF size XXL
00841277109122 - Xpert2025-02-03 Nitrile Exam Glove, PF SAMPLE PACK
00841277109221 - latex edition IC2025-02-03 Latex Exam Glove, PF size XL
00841277109221 - latex edition IC2025-02-03 Latex Exam Glove, PF size XL
00841277109290 - safe2025-02-03 Nitrile Exam Glove, PF size S

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