510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K072067Substantially Equivalent

N95 Surgical Respirator, Type Ap0018 and Ap0028

Shuenn Bao Shing Corp., Hsin Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072067 is the FDA 510(k) clearance record for N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028, a class II device, cleared for Shuenn Bao Shing Corporation on under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list 2 510(k) clearances for Shuenn Bao Shing Corporation, from to . As of , FDA records show no recalls naming K072067.

Clearance record

Decision date
Received
(165 days to decision)
Product code
MSH Respirator, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shuenn Bao Shing Corporation # 58, Fu Chiun St., Hsin Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSH

Trailing 12 months

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

FDA records show no clearances under product code MSH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSH, 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