Sempermed Syntegra Green SGR700

GUDID 00841277110821

Polyisoprene Surgical Glove PF - 7.0

Harps USA, Inc.

Polychloroprene surgical glove, non-powdered
Primary Device ID00841277110821
NIH Device Record Key73b28503-d26d-4457-9313-3ae7382a9f57
Commercial Distribution Discontinuation2025-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSempermed Syntegra Green
Version Model NumberSGR700
Catalog NumberSGR700
Company DUNS004072158
Company NameHarps USA, Inc.
Device Count50
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277110821 [Unit of Use]
GS109001570536716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGOSurgeon'S Gloves

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [Sempermed Syntegra Green]

00841277110869Polyisoprene Surgical Glove PF - 9.0
00841277110852Polyisoprene Surgical Glove PF - 8.5
00841277110845Polyisoprene Surgical Glove PF - 8.0
00841277110838Polyisoprene Surgical Glove PF - 7.5
00841277110821Polyisoprene Surgical Glove PF - 7.0
00841277110814Polyisoprene Surgical Glove PF - 6.5
00841277110807Polyisoprene Surgical Glove PF - 6.0
00841277110791Polyisoprene Surgical Glove PF - 5.5

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