FDA.reportPublic FDA data

RESIST

Primary DI
00850053354502
Brand
RESIST
Company
Poss, LLC
Model
RST100
Device description
RESIST Nitrile Exam Glove, 6.0mil, Black, Size Small, Chemo-Tested, Single Use, Box of 100
Published
2023-10-01
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053354519PackageGS110In Commercial Distribution
00850053354502PrimaryGS10
00850053354496Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053354519008500533545198500533545190850053354519
00850053354502008500533545028500533545020850053354502
00850053354496008500533544968500533544960850053354496

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
00850053354410ASSURE PLUSASRP2002023-10-01
00850053354441ASSURE PLUSASRP3002023-10-01
00850053354472ASSURE PLUSASRP3502023-10-01
00850053354533RESISTRST2002023-10-01
00850053354564RESISTRST3002023-10-01
00850053354595RESISTRST3502023-10-01
00850053354274ASSUREASR1002023-10-01
00850053354304ASSUREASR2002023-10-01

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Primary DI, Brand, Company table
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10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07
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10810141933962VIVIT SupplyVivit Supply LLCLZC2026-10-07
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10810141933979VIVIT SupplyVivit Supply LLCLZC2026-10-07
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