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FDA 510(k)

Dukal Corporation Level 1 Pediatric Face Mask

K-Number: K210321 · 2022-03-29

ApplicantDukal Corporation
Decision Date2022-03-29
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dukal Corporation Level 1 Pediatric Face Mask is a medical device manufactured by Dukal Corporation. It received FDA 510(k) clearance on 2022-03-29 under approval number K210321. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dukal Corporation Level 1 Pediatric Face Mask?

Dukal Corporation Level 1 Pediatric Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-29. It is manufactured by Dukal Corporation. The 510(k) number is K210321.

When was Dukal Corporation Level 1 Pediatric Face Mask approved by the FDA?

Dukal Corporation Level 1 Pediatric Face Mask received FDA 510(k) clearance on 2022-03-29, under approval number K210321.

What company makes Dukal Corporation Level 1 Pediatric Face Mask?

Dukal Corporation Level 1 Pediatric Face Mask is manufactured by Dukal Corporation.

What is the FDA product code for Dukal Corporation Level 1 Pediatric Face Mask?

The FDA product code for Dukal Corporation Level 1 Pediatric Face Mask is OXZ.

Related Clinical Trials

NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT06449924 An Endotracheal Tube Inserted to the Level of the Hypopharynx COMPLETED NCT07095946 Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe RECRUITING

Other Devices by Dukal Corporation

K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

Related Devices (Code: OXZ)

K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc. K201514Child Face MaskShandong Shengquan New Material Co., Ltd. K202831The iMask Child's Face MaskPac-Dent, Inc. K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc. K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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