FDA 510(k)

PRIMED Pediatric Facemask

K-Number: K213427 · 2022-11-22

Decision Date2022-11-22

Product CodeOXZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PRIMED Pediatric Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K213427. 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 PRIMED Pediatric Facemask?

PRIMED Pediatric Facemask is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K213427.

When did PRIMED Pediatric Facemask receive FDA 510(k) clearance?

PRIMED Pediatric Facemask received FDA 510(k) clearance on 2022-11-22, under 510(k) number K213427.

Who is the listed applicant for PRIMED Pediatric Facemask?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Pediatric Facemask?

The FDA product code for PRIMED Pediatric Facemask is OXZ.

Other records listing Primed Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252964PRIMED Surgical and Procedure Masks K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

Related Devices (Code: OXZ)

K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation K201514Child Face MaskShandong Shengquan New Material Co., Ltd.K202831The iMask Child's Face MaskPac-Dent, Inc.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.K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech

Official Source

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