FDA.reportPublic FDA data

ASSURE PLUS

Primary DI
00850053354410
Brand
ASSURE PLUS
Company
Poss, LLC
Model
ASRP200
Device description
ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size Medium, Blue, Chemo-Tested, Single Use, Box of 100
Published
2023-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053354427PackageGS110In Commercial Distribution
00850053354410PrimaryGS10
00850053354403Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053354427008500533544278500533544270850053354427
00850053354410008500533544108500533544100850053354410
00850053354403008500533544038500533544030850053354403

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.

Contacts#

Phone, Email table
PhoneEmail
850-661-4197support@possmedical.com

Regulatory Flags#

DUNS number
066882769
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053354717POSS MedicalP1031602025-04-01
00850053354731POSS MedicalP1031702025-04-01
00850053354694POSS MedicalP1031502025-04-01
00850053354724POSS MedicalP1031602025-04-01
00850053354748POSS MedicalP1031702025-04-01
00850053354670POSS MedicalE1041702025-02-01
00850053354687POSS MedicalE1041702025-02-01
00850053354267ASSUREASR1002023-10-01
00850053354298ASSUREASR2002023-10-01
00850053354328ASSUREASR3002023-10-01
00850053354359ASSUREASR3502023-10-01
00850053354380ASSURE PLUSASRP1002023-10-01
00850053354441ASSURE PLUSASRP3002023-10-01
00850053354472ASSURE PLUSASRP3502023-10-01
00850053354502RESISTRST1002023-10-01
00850053354533RESISTRST2002023-10-01
00850053354564RESISTRST3002023-10-01
00850053354595RESISTRST3502023-10-01
00850053354274ASSUREASR1002023-10-01
00850053354304ASSUREASR2002023-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00842942019579PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019586PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019593PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019609PRIMEDpriMED Medical Products IncLZA2026-03-12
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00842942019623PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019630PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019647PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019654PRIMEDpriMED Medical Products IncLZA2026-03-12
00842942019661PRIMEDpriMED Medical Products IncLZA2026-03-12
00810194400148AiraAIRA, LLCLZA2026-01-16
00810194400193AiraAIRA, LLCLZA2026-01-16
00842942014154PRIMEDpriMED Medical Products IncLZC2025-11-18
00842942014154PRIMEDpriMED Medical Products IncLZA2025-11-18