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510(k) K213427

PRIMED Pediatric Facemask by Primed Medical Products, Inc. — Product Code OXZ

K213427 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMED Pediatric Facemask". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code OXZ (Pediatric/Child Facemask), a Class II device regulated under 21 CFR 878.4040. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
October 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pediatric/Child Facemask
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.

Other clearances by Primed Medical Products, Inc.

  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (October 7, 2024)
  • K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks (August 26, 2024)
  • K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (May 24, 2024)
  • K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (November 4, 2016)
  • K092012 — PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL (September 25, 2009)
  • K081633 — PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (August 11, 2008)

Other clearances for product code OXZ

  • K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
  • K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 2022)
  • K201514 — Child Face Mask (October 10, 2021)
  • K202831 — The iMask Child's Face Mask (August 26, 2021)
  • K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), (September 17, 2019)
  • K160100 — Prestige Ameritech Pediatric/Child’s Face mask (October 7, 2016)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (September 23, 2011)

FDA data resources