Dexterity Nitrile PF Exam Blue XL

Primary DI
D7664332042
Brand
Dexterity Nitrile PF Exam Blue XL
Company
Smarthealth, Inc.
Model
433204
Catalog number
433204
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7664332042PackageHIBCC12In Commercial Distribution
D7664332041PrimaryHIBCC0
D7664332040Unit of UseHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
061081477
Device count
90
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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D766418932SMART TOUCH LATEX PF EXAM NATURAL MED41893418932023-07-18
D766418942 SMART TOUCH LATEX PF EXAM NATURAL LG41894418942023-07-18
D766418952 SMART TOUCH LATEX PF EXAM NATURAL XL41895418952023-07-18
D766431212 PINK RIBBON LATEX PF EXAM PNK VT BX XS43121431212023-07-18
D766431222 PINK RIBBON LATEX PF EXAM PNK VT BX SM43122431222023-07-18
D766431231 PINK RIBBON LATEX PF EXAM PNK VT BX MD43123431232023-07-18
D766431602QUALITOUCH LATEX PF L/R FIT EXAM NATURAL 6.043160431602023-07-18
D766431650QUALITOUCH LATEX PF L/R FIT EXAM NATURAL 6.543165431652023-07-18

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