FDA.reportPublic FDA data

Sentinel Guardian - Nitrile

Primary DI
00850036973348
Brand
Sentinel Guardian - Nitrile
Company
Life Science Products, Inc.
Model
G-MDNF09-LG
Device description
Blue non-sterile Nitrile exam glove, medium duty - Size Lg
Published
2024-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K223903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223903000Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)Semperit Investments Asia Pte , Ltd.2023-01-27LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850036973345PackageGS110In Commercial Distribution
00850036973348PrimaryGS10
00850036973362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003697334510850036973345
00850036973348008500369733488500369733480850036973348
00850036973362008500369733628500369733620850036973362

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.

Regulatory Flags#

DUNS number
119697365
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850036973386Sentinel Guardian - NitrileG-MDNF09-XL2024-12-30
10850036973345Sentinel Guardian - NitrileG-MDNF09-LG2024-12-30
10850036973383Sentinel Guardian - NitrileG-MDNF09-XL2024-12-30
00850036973331Sentinel Guardian - NitrileG-MDNF09-MED2024-12-26
10850036973338Sentinel Guardian - NitrileG-MDNF09-MED2024-12-26
00850036973324Sentinel Guardian - NitrileG-MDNF09-SM2024-12-18
10850036973321Sentinel Guardian - NitrileG-MDNF09-SM2024-12-18
00850036973003Sentinel Guardian - NitrileG-GNF12-Sm2022-09-23
00850036973027Sentinel Guardian - NitrileG-GNF12-Med2022-09-23
00850036973041Sentinel Guardian - NitrileG-GNF12-Lg2022-09-23
00850036973065Sentinel Guardian - NitrileG-GNF12-Xl2022-09-23
00850036973089Sentinel Guardian - NitrileG-GNF12-2xl2022-09-23
10850036973000Sentinel Guardian - NitrileG-GNF12-Sm2022-09-23
10850036973024Sentinel Guardian - NitrileG-GNF12-Med2022-09-23
10850036973048Sentinel Guardian - NitrileG-GNF12-Lg2022-09-23
10850036973062Sentinel Guardian - NitrileG-GNF12-Xl2022-09-23
10850036973086Sentinel Guardian - NitrileG-GNF12-2xl2022-09-23
00850036973102Sentinel Guardian - NitrileG-PNF09-Xsm2022-09-20
00850036973119Sentinel Guardian - LatexG-LF09-Xsm2022-09-20
00850036973140Sentinel Guardian - LatexG-LF09-Sm2022-09-20

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