NYES Tuff Cuff L3 一次性隔离衣
K号: K261949 · 2026-07-10
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决定日期2026-07-10
产品代码FYA
咨询委员会SU
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器械摘要
NYES Tuff Cuff L3 Disposable Gowns is the device name listed in this FDA 510(k) record. The listed applicant is New York Embroidery Studio. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261949. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NYES Tuff Cuff L3 Disposable Gowns?
NYES Tuff Cuff L3 Disposable Gowns is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is New York Embroidery Studio. The 510(k) number is K261949.
When did NYES Tuff Cuff L3 Disposable Gowns receive FDA 510(k) clearance?
NYES Tuff Cuff L3 Disposable Gowns received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261949.
Who is the listed applicant for NYES Tuff Cuff L3 Disposable Gowns?
The FDA 510(k) record lists New York Embroidery Studio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NYES Tuff Cuff L3 Disposable Gowns?
The FDA product code for NYES Tuff Cuff L3 Disposable Gowns is FYA.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FYA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260407原理与意愿 ANSI/AAMI PB 70（无菌/非无菌）三级手术服（加固型）和原理与意愿 ANSI/AMMI PB70（无菌/非无菌）四级手术服/隔离服Principle & Will Co., Ltd.K261028手术服 Level2（S，M，L，XL，XXL，XXXL）Yadu Medical (Henan) Co., Ltd.K252575Tuff Cuff™ 一次性手术服 AAMI L4 灭菌-大号（ML-L4-STL-DC-L）New York Embroidery Studio (NYES)K260725BAÜMER 手术服（COP01, COP04, COP05, COP10）Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™聚酯增强手术服Cardinal Health 200, LLCK253003非无菌三级手术服（4025）；无菌三级手术服（M4025）；非无菌加固四级手术服（G4025）；加固无菌四级手术服（GM4025）Hubei Xinxin Non-Woven Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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