Yadu Medical (Henan) Co., Ltd. · Class II · Cleared Feb 4, 2026
| K-number | K252301 |
| Device name | Henan Yadu Level 4 Surgical Gowns (Reinforced) |
| Applicant | Yadu Medical (Henan) Co., Ltd. |
| Product code | FYA |
| Device class | Class II |
| Decision date | Feb 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
The Henan Yadu Level 4 Surgical Gown (Reinforced) is a sterile, single-use surgical apparel intended for use by operating room personnel during surgical operations and invasive examinations. It provides a liquid and microbial barrier to protect both patients and medical staff, meeting Level 4 liquid barrier performance requirements per ANSI/AAMI PB70:2022.
The subject device uses a multi-layer nonwoven fabric composition (47g SMMMS + 35g protective film) with a reinforced polypropylene film, compared to the predicate's three-layer SMS nonwoven. Both are blue, disposable, sterile, single-use surgical gowns sterilized by ethylene oxide with similar design features including hook-and-loop neck closure, belt ties, and knit cuffs. Available sizes range from Small to XXX-Large.
ANSI/AAMI PB70:2022, ASTM F2407/F2407M-23a, AATCC TM42-2017e (water resistance impact), AATCC TM127-2017 (hydrostatic pressure), ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ASTM D5034-21 (tensile strength), ASTM D5587-15 (tear strength), ASTM F1671/F1671M-22 (bacteriophage resistance), and 16 CFR Part 1610 (flammability).
View the full FDA submission: accessdata.fda.gov