Surgical Drape with Aami Liquid Barrier Level IV
FDA 510(k) K121919 · Exact Medical Manufacturing, Inc.
510(k) numberK121919
Submission
- Device name
- Surgical Drape with Aami Liquid Barrier Level IV
- Applicant
- Exact Medical Manufacturing, Inc.
Buffalo, NY, US - Received
- July 2, 2012
- Decision date
- February 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
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| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
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| K120045 | Emm High Performance Surgical Gown with Aami Liquid Barrier Level IVFYA · Traditional | 06/12/2012SE |
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| K101598 | Emm Surgical Drape SMS W/Pe Sides Model 13-005 (with Minor Dimensional Variations for…KKX · Traditional | 10/04/2010SE |
| K101689 | Emm Equipment Cover-PolythyleneKKX · Traditional | 09/20/2010SE |
| K101688 | Emm Surgical Drape-Spunlace W/Pe Sides, Model 13-004KKX · Traditional | 09/20/2010SE |
| K101593 | Emm Surgical Gown-Sms with Pe Layer, Model 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA · Traditional | 09/03/2010SE |
Questions and answers
When was Surgical Drape with Aami Liquid Barrier Level IV cleared by the FDA?
Surgical Drape with Aami Liquid Barrier Level IV (K121919) received a 510(k) decision of Substantially Equivalent on February 14, 2013, 227 days after the submission was received.
What is the product code of K121919?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.