LYDUS

Primary DI
08859826313007
Brand
LYDUS
Company
NATHARN TRADING COMPANY LIMITED
Model
LY3100NPFNS
Catalog number
LY-NEX-STD-L
Device description
LYDUS Nitrile Examination Gloves, Powder Free
Published
2026-06-04
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

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
K203191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203191000LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd.2021-02-12LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859826313007PrimaryGS10
08859826313106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859826313007088598263130078859826313007
08859826313106088598263131068859826313106

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
Special Storage Condition, Specify00Store in a cool, dry place away from sunlight

Regulatory Flags#

DUNS number
661743714
Device count
100
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
08859826311003LYDUSLY1100NPFNSLY-NEX-STD-S2026-06-04
08859826312000LYDUSLY2100NPFNSLY-NEX-STD-M2026-06-04
08859826314004LYDUSLY4100NPFNSLY-NEX-STD-XL2026-06-04
NTC08187899532LydusLY2100NPFNS12022-02-27
NTC08187899533LydusLY3100NPFNS12022-02-27
NTC08187899534LydusLY4100NPFNS12022-02-27
NTC08187899535LydusLY1100NPFNS22022-02-27
NTC08187899536LydusLY2100NPFNS22022-02-27
NTC08187899537LydusLY3100NPFNS22022-02-27
NTC08187899538LydusLY4100NPFNS22022-02-27
NTC08187899531LydusLY1100NPFNS12022-02-27
LY08126698042LydusLY2100NPFNS12022-02-27
LY081266980423LydusLY3100NPFNS12022-02-27
LY081266980424LydusLY4100NPFNS12022-02-27
LY0812669804285LydusLY1100NPFNS22022-02-27
LY0812669804286LydusLY2100NPFNS22022-02-27
LY0812669804287LydusLY3100NPFNS22022-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
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00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
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