Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X)
FDA 510(k) K032631 · Lac Mac, Ltd.
510(k) numberK032631
Submission
- Device name
- Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X)
- Applicant
- Lac Mac, Ltd.
Austin, TX, US - Received
- August 26, 2003
- Decision date
- February 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K102864 | 84E Series Single Ply WrapperFRG · Traditional | 01/14/2011SE |
| K092344 | Lac-Mac Innerbloc LR Surgical GownsFYA · Abbreviated | 12/17/2009SE |
| K061491 | Lac-Mac Innerbloc O.R. GownFYA · Abbreviated | 08/09/2006SE |
| K031362 | Lac-Mac Limited Innerbloc Various O.R. Drape Based on the Repel, Plus and Gore Surgical…KKX · Traditional | 05/30/2003SE |
| K030536 | Lac-Mac Limited Innerbloc O.R. GownFYA · Traditional | 05/06/2003SE |
Questions and answers
When was Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X) cleared by the FDA?
Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X) (K032631) received a 510(k) decision of Substantially Equivalent on February 5, 2004, 163 days after the submission was received.
What is the product code of K032631?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.