DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XS 431221

GUDID D7664312212

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Primary Device ID	D7664312212
NIH Device Record Key	c068143b-d63e-40a4-98ca-648f34725287
Commercial Distribution Status	In Commercial Distribution
Brand Name	DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XS
Version Model Number	431221
Catalog Number	431221
Company DUNS	061081477
Company Name	Smarthealth, Inc.
Device Count	300
DM Exempt	false
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	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7664312210 [Unit of Use]
HIBCC	D7664312211 [Primary]
HIBCC	D7664312212 [Package] Contains: D7664312211 Package: case [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171422

FDA Product Code

LZA	Polymer Patient Examination Glove

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-06
Device Publish Date	2022-11-28

Devices Manufactured by Smarthealth, Inc.

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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