FDA.reportPublic FDA data

SemperSure Green Nitrile Exam Glove

Primary DI
00841277105490
Brand
SemperSure Green Nitrile Exam Glove
Company
Harps USA, Inc.
Model
SUNG205
Catalog number
SUNG205
Device description
SemperSure Green Nitrile Exam Glove, size XL
Published
2020-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183441000Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy DrugsSemperit Investments Asia Pte , Ltd.2019-10-04LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277105490PrimaryGS10
00841277105506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277105490008412771054908412771054900841277105490
00841277105506008412771055068412771055060841277105506

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-366-9545Glove.Info@SempermedUSA.com

Regulatory Flags#

DUNS number
004072158
Device count
200
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09001570557278Sempermed Syntegra GreenSGR550SGR5502026-05-21
09001570557308Sempermed Syntegra GreenSGR600SGR6002026-05-21
09001570557339Sempermed Syntegra GreenSGR650SGR6502026-05-21
09001570557360Sempermed Syntegra GreenSGR700SGR7002026-05-21
09001570557391Sempermed Syntegra GreenSGR750SGR7502026-05-21
09001570557421Sempermed Syntegra GreenSGR800SGR8002026-05-21
09001570557452Sempermed Syntegra GreenSGR850SGR8502026-05-21
09001570557483Sempermed Syntegra GreenSGR900SGR9002026-05-21
09001570557797Sempermed Syntegra preCisionSPR550SPR5502026-05-21
09001570557827Sempermed Syntegra preCisionSPR600SPR6002026-05-21
09001570557858Sempermed Syntegra preCisionSPR650SPR6502026-05-21
09001570557889Sempermed Syntegra preCisionSPR700SPR7002026-05-21
09001570557919Sempermed Syntegra preCisionSPR750SPR7502026-05-21
09001570557940Sempermed Syntegra preCisionSPR800SPR8002026-05-21
09001570557971Sempermed Syntegra preCisionSPR850SPR8502026-05-21
09001570558008Sempermed Syntegra preCisionSPR900SPR9002026-05-21
09001570557285Sempermed Syntegra GreenSGR550SGR5502026-02-12
09001570557315Sempermed Syntegra GreenSGR600SGR6002026-02-12
09001570557346Sempermed Syntegra GreenSGR650SGR6502026-02-12
09001570557377Sempermed Syntegra GreenSGR700SGR7002026-02-12

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Primary DI, Brand, Company table
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