Sempermed Rose SMNR201

GUDID 00841277110012

Sempermed Rose Nitrile Exam Glove, size XS

SEMPERMED USA, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00841277110012
NIH Device Record Key663fffaf-054c-497e-9f93-3df65c7c4b4a
Commercial Distribution Discontinuation2025-03-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSempermed Rose
Version Model NumberSMNR201
Catalog NumberSMNR201
Company DUNS004072158
Company NameSEMPERMED USA, INC.
Device Count200
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277109955 [Primary]
GS100841277110012 [Unit of Use]

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 Date2025-03-25
Device Publish Date2025-03-17

On-Brand Devices [Sempermed Rose]

00841277110067Sempermed Rose Nitrile Exam Glove, sample pack
00841277110050Sempermed Rose Nitrile Exam Glove, size XL
00841277110036Sempermed Rose Nitrile Exam Glove, size M
00841277110029Sempermed Rose Nitrile Exam Glove, size S
00841277110012Sempermed Rose Nitrile Exam Glove, size XS

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.