FDA.reportPublic FDA data

Pentagon Safety Equipment

Primary DI
00850044884278
Brand
Pentagon Safety Equipment
Company
Pacific Merchants Alliance LLC
Model
N2E-7-HR-B-XXL-1000
Device description
D-Day Nitrile Exam Gloves Size XXL Full Case
Published
2022-10-05
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044884278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044884278008500448842788500448842780850044884278

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
081227785
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044884087Pentagon Safety EquipmentN2E-7-HR-B-M-1002022-10-05
00850044884094Pentagon Safety EquipmentN2E-7-HR-B-L-1002022-10-05
00850044884100Pentagon Safety EquipmentN2E-7-HR-B-XL-1002022-10-05
00850044884117Pentagon Safety EquipmentN2E-7-HR-B-XXL-1002022-10-05
00850044884124X Factor ScientificVN3E-5.5-MR-BU-M-1002022-10-05
00850044884131X Factor ScientificVN3E-5.5-MR-BU-L-1002022-10-05
00850044884148X Factor ScientificVN3E-5.5-MR-BU-XL-1002022-10-05
00850044884186X Factor ScientificN2S-4-N-TXBU-M-10002022-10-05
00850044884193X Factor ScientificN2S-4-N-TXBU-M-10002022-10-05
00850044884209X Factor ScientificN2S-4-N-TXBU-L-10002022-10-05
00850044884216X Factor ScientificN2S-4-N-TXBU-XL-10002022-10-05
00850044884223X Factor ScientificN2S-4-N-TXBU-XXL-10002022-10-05
00850044884230X Factor ScientificN3-3-E-B-S-20002022-10-05
00850044884247Pentagon Safety EquipmentN2E-7-HR-B-M-10002022-10-05
00850044884254Pentagon Safety EquipmentN2E-7-HR-B-L-10002022-10-05
00850044884261Pentagon Safety EquipmentN2E-7-HR-B-XL-10002022-10-05
00850044884285X Factor ScientificN3-3-E-B-M-20002022-10-05
00850044884292X Factor ScientificN3-3-E-B-L-20002022-10-05
00850044884308X Factor ScientificN3-3-E-B-XL-20002022-10-05
00850044884315X Factor ScientificN3-3-E-B-XXL-20002022-10-05

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Primary DI, Brand, Company table
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00811114033026TopGripUnisafe Inc.LZA2026-08-14
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00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31