FDA.reportPublic FDA data

PrimaPro

Primary DI
00850022371127
Brand
PrimaPro
Company
PRIMARY PRODUCTS COMPANY
Model
231-45
Device description
PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single-Use
Published
2020-09-09
Public version status
Update
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
10850022371124PackageGS110In Commercial Distribution
00850022371127PrimaryGS10
20850022371121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002237112410850022371124
00850022371127008500223711278500223711270850022371127
2085002237112120850022371121

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
089569581
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022371424PrimaPro611-452020-09-09
00850022371431PrimaPro612-452020-09-09
00850022371448PrimaPro613-452020-09-09
00850022371455PrimaPro614-452020-09-09
00850022371523PrimaPro421-452020-12-30
00850022371530PrimaPro422-452020-12-30
00850022371547PrimaPro423-452020-12-30
00850022371554PrimaPro424-452020-12-30
00850022371561PrimaPro610-45420-45N2026-04-28
00850022371578PrimaPro525-452025-02-12
00850022371585PrimaPro520-452025-02-12
00850022371622PrimaPro275-452025-02-12
10850022371575PrimaPro525-452025-02-12
10850022371582PrimaPro520-452025-02-12
10850022371629PrimaPro275-452025-02-12
00850022371301PrimaPro311-452020-09-09
00850022371318PrimaPro312-452020-09-09
00850022371325PrimaPro313-452020-09-09
00850022371332PrimaPro314-452020-09-09
00850022371479PrimaProW182028EL-BX2020-09-18

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Primary DI, Brand, Company table
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10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
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