FDA.reportPublic FDA data

Schneider

Primary DI
00850028934081
Brand
Schneider
Company
Avatech Corp.
Model
NBFK7100
Device description
Schneider Disposable Powder-Free Nitrile Exam Gloves, 4 mil, Black, NBFK7100, 100ct Box, Size XS
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028934920PackageGS110In Commercial Distribution
00850028934081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028934920008500289349208500289349200850028934920
00850028934081008500289340818500289340810850028934081

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature41 Degrees Fahrenheit100 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(866) 598-7755support@schneidercare.com

Regulatory Flags#

DUNS number
073477685
Device count
1
Lot or batch
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
00810112473667SwiftGripEN35WC02026-01-23
00810112473674SwiftGripEN35WC12026-01-23
00810112473698SwiftGripEN35WC32026-01-23
00810112473704SwiftGripEN35WC42026-01-23
00810112473711SwiftGripEN35WC52026-01-23
00810112473780SwiftGripEN35WD02026-01-23
00810112473803SwiftGripEN35WD22026-01-23
00810112473810SwiftGripEN35WD32026-01-23
00810112473827SwiftGripEN35WD42026-01-23
00810112473834SwiftGripEN35WD52026-01-23
00810112473728SwiftGripEN35WC02026-01-23
00810112473735SwiftGripEN35WC12026-01-23
00810112473759SwiftGripEN35WC32026-01-23
00810112473766SwiftGripEN35WC42026-01-23
00810112473773SwiftGripEN35WC52026-01-23
00810112473841SwiftGripEN35WD02026-01-23
00810112473797SwiftGripEN35WD12026-01-23
00810112473865SwiftGripEN35WD22026-01-23
00810112473872SwiftGripEN35WD32026-01-23
00810112473889SwiftGripEN35WD42026-01-23

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