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Disposable Surgical Gown HF01

by Zhejiang Huafu Medical Equipment Co., Ltd. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16970145500448 UDI-DI Date8 Apr 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Disposable Surgical Gown
Generic Name
Surgical gown, single-use
Model / Ref / Catalog
HF01
Primary DI / UDI-DI
16970145500448
FDA Product Code
FYA
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical gown, single-use

Other devices from Zhejiang Huafu Medical Equipment Co., Ltd.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No