FDA.reportPublic FDA data

SUPMEDIC

Primary DI
00810160180401
Brand
SUPMEDIC
Company
Supmedics Inc.
Model
SKF 4302
Device description
Powder Free Nitrile Examination Gloves (S size)
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K213040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213040000Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy DrugsGuangdong Kingfa Sci. & Tech.Co., Ltd.2022-04-27LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810160180449PackageGS110In Commercial Distribution
00810160180401PrimaryGS10
00810160181996Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810160180449008101601804498101601804490810160180449
00810160180401008101601804018101601804010810160180401
00810160181996008101601819968101601819960810160181996

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
Width80Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
107150886
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810160180005BEASTEKBTN14422024-11-04
00810160180012BEASTEKBTN14432024-11-04
00810160180043BeastekBTN24422024-10-02
00810160183549supUNE-XL-151052026-01-26
08101601833584supUNE-S-131022026-01-26
08101601833652supUNE-M-131032026-01-26
08101601833720supUNE-L-131042026-01-26
08101601833898supUNE-XL-131052026-01-26
08101601834338supUNE-S-141022026-01-26
08101601834406supUNE-M-141032026-01-26
08101601834574supUNE-L-141042026-01-26
08101601834642supUNE-XL-141052026-01-26
08101601835182supUNE-S-151022026-01-26
08101601835250supUNE-M-151032026-01-26
08101601835328supUNE-L-151042026-01-26
08101601835946supUNE-S-161022026-01-26
08101601836004supUNE-M-161032026-01-26
08101601836172supUNE-L-161042026-01-26
08101601836240supUNE-XL-161052026-01-26
08101601836790SUPUNM-S-141122026-01-26

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Primary DI, Brand, Company table
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08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
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20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
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