Le soothe Latex PF L/R FIT Exam Natural 8.5 43785N

GUDID D76643785N2

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Primary Device ID	D76643785N2
NIH Device Record Key	53d23bcc-1f71-458b-bdb4-9fc3e8c8956d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Le soothe Latex PF L/R FIT Exam Natural 8.5
Version Model Number	43785N
Catalog Number	43785N
Company DUNS	061081477
Company Name	Smarthealth, Inc.
Device Count	50
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Issuing Agency	Device ID
HIBCC	D76643785N0 [Unit of Use]
HIBCC	D76643785N1 [Primary]
HIBCC	D76643785N2 [Package] Contains: D76643785N1 Package: case [10 Units] In Commercial Distribution

LYY	Latex Patient Examination Glove

Steralize Prior To Use	false
Device Is Sterile	false

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D7664311072 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM	2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM*200
D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED	2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200
D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG	2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200
D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL	2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200
D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS*	2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100
D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM	2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100
D766408732 - QUALITOUCH LATEX PF EXAM NATURAL CF MD	2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF MED*100