Milglove

Primary DI
00811114031985
Brand
Milglove
Company
Unisafe Inc.
Model
N5SM
Device description
Powder-Free Nitrile Examination Gloves
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K230121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230121000Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)Careglove Global Sdn. Bhd.2023-05-15LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811114031985PackageGS110In Commercial Distribution
00811114031930PrimaryGS10
10811114031937Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811114031985008111140319858111140319850811114031985
00811114031930008111140319308111140319300811114031930
1081111403193710811114031937

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080171627
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
false
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
00811114031602ProglovePGV500M2026-05-21
00811114031596ProglovePGV500S2026-05-20
00811114031619ProglovePGV500L2026-05-20
00811114031626ProglovePGV500XL2026-05-20
00811114031930MilgloveN5SM2025-04-11
00811114031947MilgloveN5MD2025-04-11
00811114031954MilGloveN5LG2025-04-11
00811114031961MilgloveN5XL2025-04-11
00811114031978MilgloveN5XXL2025-04-11
00811114032029MilgloveN5MD2025-04-11
00811114031992MilGloveN5LG2025-04-11
00811114032005MilgloveN5XL2025-04-11
00811114032012MilgloveN5XXL2025-04-11
00811114030605Black PythonPY700S2023-07-31
00811114030612Black PythonPY700M2023-07-31
00811114030629Black PythonPY700L2023-07-31
00811114030636Black PythonPY700XL2023-07-31
00811114030704CopperheadCH500S2023-07-31
00811114030735CopperheadCH500L2023-07-31
00811114030742CopperheadCH500XL2023-07-31

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20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
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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
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