Medline, Gore-Tex Barrier, Surgical Gowns & Drapes
FDA 510(k) K915502 · Medline
510(k) numberK915502
Submission
- Device name
- Medline, Gore-Tex Barrier, Surgical Gowns & Drapes
- Applicant
- Medline
Mundelein, IL, US - Received
- December 9, 1991
- Decision date
- April 29, 1992
- 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.
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| K120156 | Pureimage Ultrasound Transmission GelITX · Traditional | 02/08/2012SE |
| K051378 | Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)LZA · Traditional | 08/03/2005SE |
| K010825 | Medline Steriset Sterilization ContainerFRG · Traditional | 05/08/2001SE |
| K990463 | Medline Excel WheelchairsIOR · Traditional | 03/15/1999SE |
| K970282 | Medline Circumcision TrayHFX · Traditional | 03/06/1997SE |
| K963504 | Medline Open End Finger Control MittFMQ · Traditional | 10/29/1996SE |
| K963452 | Medline Zipper Sleeved VestFMQ · Traditional | 10/18/1996SE |
| K951736 | Lock-UpFMI · Traditional | 07/05/1995SE |
| K932033 | Laparoscopic Surgery InstrumentsGCJ · Traditional | 06/19/1995SE |
| K932060 | Martin Cold Light FountainGCJ · Traditional | 03/30/1994SE |
Questions and answers
When was Medline, Gore-Tex Barrier, Surgical Gowns & Drapes cleared by the FDA?
Medline, Gore-Tex Barrier, Surgical Gowns & Drapes (K915502) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 142 days after the submission was received.
What is the product code of K915502?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.