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

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

21 CFR 878.4040 / General, Plastic Surgery
FDA source (opens on fda.gov)

QPC is the FDA product code for Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code 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 excluded". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QPC
Device name
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
FDA definition
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 excluded.
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code QPC

By decision year
12 clearances under product code QPC with a decision year between 2017 and 2026, 2021 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QPC by decision year
YearClearances
20171
20191
20212
20221
20232
20241
20252
20262

Applicants with the most clearances

Product code QPC
Applicants holding the most 510(k) clearances under product code QPC
ApplicantClearances
Polyconversions, Inc.3
AZAC Group1
Bam Corporation Limited1
Cadillac Products, Inc.1
Cardinal Health200, LLC1
Dong Nai Garment Corporation (Donagamex)1
Dukal LLC1
Kenpax International Limited1
MEDLINE INDUSTRIES, LP - Northfield1
PRIMED Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order