FDA.reportPublic FDA data

METRO-PACIFICA

Primary DI
00609626063378
Brand
METRO-PACIFICA
Company
Metro Medical Supply
Model
AN-1080
Catalog number
AN-1080
Device description
NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; Large
Published
2019-04-26
Public version status
Update
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
LZCPatient examination glove, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609626063361PackageGS110In Commercial Distribution
00609626063378PrimaryGS10
00609626063385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609626063361006096260633616096260633610609626063361
00609626063378006096260633786096260633780609626063378
00609626063385006096260633856096260633850609626063385

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
080604969
Device count
200
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609626063101METRO-PACIFICANPF-1150NPF-11502019-04-26
00609626063132METRO-PACIFICANPF-1160NPF-11602019-04-26
00609626063163METRO-PACIFICANPF-1170NPF-11702019-04-26
00609626063194METRO-PACIFICANPF-1180NPF-11802019-04-26
00609626063224METRO-PACIFICANPF-1190NPF-11902019-04-26
00609626063255METRO-PACIFICANPF-1195NPF-11952019-04-26
00609626063439METRO-PACIFICAAN-2550AN-25502019-04-26
00609626063460METRO-PACIFICAAN-2560AN-25602019-04-26
00609626063491METRO-PACIFICAAN-2570AN-25702019-04-26
00609626063521METRO-PACIFICAAN-2580AN-25802019-04-26
00609626063552METRO-PACIFICAAN-2590AN-25902019-04-26
00609626000007Metro-PacificaELM-9702018-09-20
00609626000021Metro-PacificaELM-9702018-09-20
00609626000038Metro-PacificaELM-9802018-10-01
00609626062630Metro-PacificaELM-9802018-10-01
00609626062647Metro-PacificaELM-970ES2018-10-01
00609626062661Metro-PacificaELM-970ES2018-10-01
00609626000199METRO-PACIFICAT-1060T-10602019-06-12
00609626000229METRO-PACIFICAT-1070T-10702019-06-12
00609626000250METRO-PACIFICAT-1080T-10802019-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12