Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV
FDA 510(k) K120045 · Exact Medical Manufacturing, Inc.
510(k) numberK120045
Submission
- Device name
- Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV
- Applicant
- Exact Medical Manufacturing, Inc.
Buffalo, NY, US - Received
- January 6, 2012
- Decision date
- June 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYA – Gown, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional | Principle & Will Co., Ltd. | 08/26/2026SE |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 08/07/2026SE |
| K261949 | NYES Tuff Cuff L3 Disposable GownsFYA · Special | New York Embroidery Studio | 07/10/2026SE |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional | New York Embroidery Studio (NYES) | 06/04/2026SE |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional | Hindernis DE Mexico, S.A.P.I. DE C.V. | 05/12/2026SE |
| K253243 | Cardinal Health Poly Reinforced Surgical GownFYA · Abbreviated | Cardinal Health 200, LLC | 04/28/2026SE |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 04/20/2026SE |
| K251860 | Copioumed AAMI 3 Surgical GownFYA · Traditional | Copioumed International, Inc. | 02/26/2026SE |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 02/04/2026SE |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 12/03/2025SE |
More from Yadu Medical (Henan) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222460 | Intraoperative Ultrasound Probe CoverITX · Traditional | 05/12/2023SE |
| K211969 | EMM Ultrasonic Transducer CoverITX · Traditional | 08/13/2021SE |
| K121919 | Surgical Drape with Aami Liquid Barrier Level IVKKX · Traditional | 02/14/2013SE |
| K111535 | Emm Surgical Gown - Spunlace with Pe LayerFYA · Traditional | 08/26/2011SE |
| 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 Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV cleared by the FDA?
Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV (K120045) received a 510(k) decision of Substantially Equivalent on June 12, 2012, 158 days after the submission was received.
What is the product code of K120045?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.