FDA.reportPublic FDA data

CUFF FIRST - NITRILE BLUE

Primary DI
00860013366537
Brand
CUFF FIRST - NITRILE BLUE
Company
CUFF FIRST INC.
Model
CF000BN
Published
2025-03-25
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
10860013366534PackageGS116In Commercial Distribution
00860013366537PrimaryGS10
00860013366551Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001336653410860013366534
00860013366537008600133665378600133665370860013366537
00860013366551008600133665518600133665510860013366551

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.

Contacts#

Phone, Email table
PhoneEmail
(646)2963836mbs101@gmail.com

Regulatory Flags#

DUNS number
119468310
Device count
125
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013366506CUFF FIRST - NITRILE BLUECF001BN2025-03-25
00860013366513CUFF FIRST - NITRILE BLUECF002BN2025-03-25
00860013366520CUFF FIRST - NITRILE BLUECF003BN2025-03-25
00860013366544CUFF FIRST - NITRILE BLUECF004BN2025-03-25
10860013366503CUFF FIRST - NITRILE BLUECF001BN2025-03-25
10860013366510CUFF FIRST - NITRILE BLUECF002BN2025-03-25
10860013366527CUFF FIRST - NITRILE BLUECF003BN2025-03-25
10860013366534CUFF FIRST - NITRILE BLUECF000BN2025-03-25
10860013366541CUFF FIRST - NITRILE BLUECF004BN2025-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00366975065506Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22