Plus Surgical Drapes (EO Sterilized), PMDB-XXX— 510(k) K133080

Substantially Equivalent

Foshan Nanhai Plus Medical Co, Ltd.

FDA 510(k) clearance K133080 for Plus Surgical Drapes (EO Sterilized), PMDB-XXX, Substantially Equivalent on 2015-06-24. Applicant: Foshan Nanhai Plus Medical Co, Ltd.. Device class: 2.

Clearance details

Applicant: Foshan Nanhai Plus Medical Co, Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2013-09-30
Decision date: 2015-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Foshan Nanhai Plus Medical Co, Ltd.

K222480 — Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)2022-11-14
K213177 — Plus Medical Cover Gown2022-05-11
K211036 — Plus Medical Chemotherapy Gown2022-05-04
K212698 — Plus Medical Isolation Gown Level 32022-03-02
K212610 — Surgical Face Mask2022-01-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.