DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XL 431225

GUDID D7664312252

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	D7664312252
NIH Device Record Key	449b80be-4cf6-4a43-ba6d-2b84c3d176b7
Commercial Distribution Status	In Commercial Distribution
Brand Name	DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XL
Version Model Number	431225
Catalog Number	431225
Company DUNS	061081477
Company Name	Smarthealth, Inc.
Device Count	250
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	D7664312250 [Unit of Use]
HIBCC	D7664312251 [Primary]
HIBCC	D7664312252 [Package] Contains: D7664312251 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

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