SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo
FDA 510(k) K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co.
510(k) numberK102692
Submission
- Device name
- SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo
- Applicant
- Hangzhou Jincheng Medical Supplier Manufacture Co.
Pennington, NJ, US - Received
- September 20, 2010
- Decision date
- March 11, 2011
- 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 |
Questions and answers
When was SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo cleared by the FDA?
SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo (K102692) received a 510(k) decision of Substantially Equivalent on March 11, 2011, 172 days after the submission was received.
What is the product code of K102692?
The FDA product code is FYA – Gown, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.