Convertors Surgical Gowns
FDA 510(k) K991034 · Allegiance Healthcare Corp.
510(k) numberK991034
Submission
- Device name
- Convertors Surgical Gowns
- Applicant
- Allegiance Healthcare Corp.
Mcgraw Park, IL, US - Received
- March 29, 1999
- Decision date
- April 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K023673 | Airlife Demand Nasal CannulaNFB · Traditional | 05/02/2003SE |
| K023602 | Small Volume NebulizerCAF · Special | 05/01/2003SE |
| K023419 | Trilaminate Drapes/TiburonKKX · Traditional | 02/11/2003SE |
| K024120 | Modification to Temno Biopsy NeedlesFCG · Special | 01/15/2003SE |
| K024292 | Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and…LYY · Special | 01/09/2003SE |
| K024102 | Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimLYY · Special | 12/18/2002SE |
| K023425 | Drapes with Absorbent ReinforcementKKX · Special | 11/06/2002SE |
| K022765 | Nitrile Powder-Free Examination GlovesLZA · Traditional | 10/11/2002SE |
| K023170 | Nitrile Powder-Free Examination GlovesLZA · Special | 10/09/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | 10/02/2002SE |
Questions and answers
When was Convertors Surgical Gowns cleared by the FDA?
Convertors Surgical Gowns (K991034) received a 510(k) decision of Substantially Equivalent on April 16, 1999, 18 days after the submission was received.
What is the product code of K991034?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.