FDA.reportPublic FDA data

767PF Series

Primary DI
10850020255907
Brand
767PF Series
Company
SUMMIT GLOVE INC.
Model
76750PF-XL
Device description
4mil, 9.5" in Length, Ambidextrous, Examination Grade Glove, Powder Free, Diamond Pattern, Blue, Size X-Large Sample Pack
Published
2020-08-17
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
K990878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990878000BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)Brightway Holdings Sdn. Bhd.1999-05-21LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850020255907PackageGS11200In Commercial Distribution
00850020255900PrimaryGS10
00850020255917Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002025590710850020255907
00850020255900008500202559008500202559000850020255900
00850020255917008500202559178500202559170850020255917

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
4
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
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00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29
00850005229612NeuflexMedgluv Inc.LZA2026-06-29
00810145951972NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951989NeuPro 16Medgluv Inc.LZA2026-06-26
00810145951996NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952009NeuPro 16Medgluv Inc.LZA2026-06-26