510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222128Substantially Equivalent

Protective Gown AAMI Level 4

Kenpax International Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K222128 is the FDA 510(k) clearance record for Protective Gown AAMI Level 4, a class II device, cleared for Kenpax International Limited on under FDA product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection). FDA's definition for product code QPC reads: "A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are...". FDA records list 4 510(k) clearances for Kenpax International Limited, from to . As of , FDA records show no recalls naming K222128.

Clearance record

Decision date
Received
(386 days to decision)
Product code
QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kenpax International Limited Flat 5, 5/F, Wing On Plz., 62 Mody Rd., Hong Kong, CN
510(k) summary
Statement
Third party review
No

Clearances, product code QPC

Trailing 12 months
3 clearances under product code QPC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QPC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260