510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201514Substantially Equivalent

Child Face Mask

Shandong Shengquan New Material Co., Ltd., Jinan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K201514 is the FDA 510(k) clearance record for Child Face Mask, a class II device, cleared for Shandong Shengquan New Material Co., Ltd. on under FDA product code OXZ (Pediatric/Child Facemask). FDA's definition for product code OXZ reads: "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...". FDA records list 3 510(k) clearances for Shandong Shengquan New Material Co., Ltd., from to . As of , FDA records show no recalls naming K201514.

Clearance record

Decision date
Received
(489 days to decision)
Product code
OXZ Pediatric/Child Facemask
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone,, Jinan, CN
510(k) summary
Statement
Third party review
No

Clearances, product code OXZ

Trailing 12 months

FDA records hold no clearances under product code OXZ in the trailing twelve months.

FDA records show no clearances under product code OXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260