FDA 510(k)

VR®个人防护三级隔离服（VR隔离服）

K号: K252940 · 2025-12-16

决定日期2025-12-16

产品代码QPC

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决定实质等同

器械摘要

VR® Personal Protective Level 3 Gown (VR Gowns) is the device name listed in this FDA 510(k) record. The listed applicant is PolyConversions, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252940. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VR® Personal Protective Level 3 Gown (VR Gowns)?

VR® Personal Protective Level 3 Gown (VR Gowns) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is PolyConversions, Inc.. The 510(k) number is K252940.

When did VR® Personal Protective Level 3 Gown (VR Gowns) receive FDA 510(k) clearance?

VR® Personal Protective Level 3 Gown (VR Gowns) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252940.

Who is the listed applicant for VR® Personal Protective Level 3 Gown (VR Gowns)?

FDA 510(k)记录中列出PolyConversions, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for VR® Personal Protective Level 3 Gown (VR Gowns)?

The FDA product code for VR® Personal Protective Level 3 Gown (VR Gowns) is QPC.

列明PolyConversions, Inc.为申报人的其他记录

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。

K261115VR®个人防护级4级隔离服（VR隔离服）K230384PolyWear® 个人防护三级隔离服

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。