FDA.reportPublic FDA data

Get-A-Grip

Primary DI
10854947005621
Brand
Get-A-Grip
Company
SUMMIT GLOVE INC.
Model
79740PF-BKGR
Device description
5mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Raised Diamond Pattern, Beaded Cuff, Black, Size Large
Published
2020-08-01
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
LZAPolymer patient examination glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060402000BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)Brightway Holdings Sdn. Bhd.2006-06-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854947005621PackageGS110Not in Commercial Distribution
00854947005624PrimaryGS10
00854947005631Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085494700562110854947005621
00854947005624008549470056248549470056240854947005624
00854947005631008549470056318549470056310854947005631

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)868-0066klynn@summitglove.com

Regulatory Flags#

DUNS number
054386458
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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