FDA.reportPublic FDA data

Schneider

Primary DI
00850028934883
Brand
Schneider
Company
Avatech Corp.
Model
NBFT7013
Device description
Schneider Disposable Powder-Free Nitrile Exam Gloves, 4 mil, Blue, NBFT7013, 50ct Box, Size L
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028934883PackageGS120In Commercial Distribution
00850028934470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028934883008500289348838500289348830850028934883
00850028934470008500289344708500289344700850028934470

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
073477685
Device count
1
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
true
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
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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Primary DI, Brand, Company table
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00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
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00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03