FDA.reportPublic FDA data

Get-A-Grip

Primary DI
00150042054308
Brand
Get-A-Grip
Company
SUMMIT GLOVE INC.
Model
79750PF-BKGR
Device description
Get-A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentanyl,Heroin and Gastric Acid Size XL CTN
Published
2022-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220373000Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)Summit Glove, Inc.2022-04-13LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00150042054308PackageGS1900In Commercial Distribution
00850042054307PrimaryGS10
00850042054314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00150042054308001500420543081500420543080150042054308
00850042054307008500420543078500420543070850042054307
00850042054314008500420543148500420543140850042054314

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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
+1(330)868-0066tcalkins@summitglove.com

Regulatory Flags#

DUNS number
054386458
Device count
90
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018374101AmbiNitrile570-BL-72020-08-01
00850018374125AmbiNitrile570-BL-82020-08-01
00850018374149AmbiNitrile570-BL-92020-08-01
00850018374163AmbiNitrile570-BL-102020-08-01
00850018374187AmbiNitrile570-BL-112020-08-01
00850018374200AmbiNitrile570-GR-72020-08-01
00850018374224AmbiNitrile570-GR-82020-08-01
00850018374248AmbiNitrile570-GR-92020-08-01
00850018374262AmbiNitrile570-GR-102020-08-01
00850018374286AmbiNitrile570-GR-112020-08-01
00850018374620NitriTech76720PF-S2020-08-01
00850018374644NitriTech76730PF-M2020-08-01
00850018374668NitriTech76740PF-L2020-08-01
00850018374682NitriTech76750PF-XL2020-08-01
00850018374705NitriTech76760PF-2XL2020-08-01
00850018374729NitriTech76770PF-3XL2020-08-01
00850019992083ResQ-Grip79720PF-BKGR2020-08-01
00850019992106ResQ-Grip79730PF-BKGR2020-08-01
00850019992120ResQ-Grip79740PF-BKGR2020-08-01
00850019992144ResQ-Grip79750PF-BKGR2020-08-01

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Primary DI, Brand, Company table
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00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.QDO2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.QDO2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.QDO2026-07-14
00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810145952115NeuleafMedgluv Inc.QDO2026-06-30
00810145952122NeuleafMedgluv Inc.QDO2026-06-30
00810145952139NeuleafMedgluv Inc.QDO2026-06-30
00810145952146NeuleafMedgluv Inc.QDO2026-06-30
00810145952429NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952436NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952443NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952450NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952467NitraGrip Pro 100Medgluv Inc.QDO2026-06-30
00810145952108NeuleafMedgluv Inc.QDO2026-06-29
00850005229568NeuflexMedgluv Inc.QDO2026-06-29
00850005229575NeuflexMedgluv Inc.QDO2026-06-29
00850005229582NeuflexMedgluv Inc.QDO2026-06-29
00850005229599NeuflexMedgluv Inc.QDO2026-06-29
00850005229605NeuflexMedgluv Inc.QDO2026-06-29
00850005229612NeuflexMedgluv Inc.QDO2026-06-29