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510(k) K201514

Child Face Mask by Shandong Shengquan New Material Co., Ltd. — Product Code OXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2021
Date Received
June 8, 2020
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 Shandong Shengquan New Material Co., Ltd.

  • K201629 — Medical Face Mask (December 14, 2020)
  • K201537 — Protective Face Mask for Medical Use (September 4, 2020)

Other clearances for product code OXZ

  • K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 2022)
  • 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)