FDA.reportPublic FDA data

SemperShield CR Chloroprene Exam Glove

Primary DI
00841277102970
Brand
SemperShield CR Chloroprene Exam Glove
Company
Harps USA, Inc.
Model
SSCR104
Catalog number
SSCR104
Device description
SemperShield CR Chloroprene Exam Glove, size L
Published
2020-01-01
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277102970PrimaryGS10
00841277103984Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277102970008412771029708412771029700841277102970
00841277103984008412771039848412771039840841277103984

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile device made of polychloroprene (neoprene) 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 talcum powder and it does not have antimicrobial features. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
100
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08