Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRIMED Pediatric Facemask

K-Number: K213427 · 2022-11-22

ApplicantPrimed Medical Products, Inc.
Decision Date2022-11-22
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMED Pediatric Facemask is a medical device manufactured by Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2022-11-22 under approval 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. It is manufactured by Primed Medical Products, Inc.. The 510(k) number is K213427.

When was PRIMED Pediatric Facemask approved by the FDA?

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

What company makes PRIMED Pediatric Facemask?

PRIMED Pediatric Facemask is manufactured by Primed Medical Products, Inc..

What is the FDA product code for PRIMED Pediatric Facemask?

The FDA product code for PRIMED Pediatric Facemask is OXZ.

Other Devices by Primed Medical Products, Inc.

K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3) 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) K252964PRIMED Surgical and Procedure Masks

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. K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation 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.

↑