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Hygitech Hy-519

by Hygitech

Hygitech Hy-519 is a Class I device made by Hygitech, listed in FDA GUDID since 15 Dec 2020 (UDI-DI 03615140002325), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03615140002325 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Hygitech
Generic name
Surgical gown, single-use
Model / Ref / Catalog
HY-519
Primary DI / UDI-DI
03615140002325
FDA product code
FME
GMDN term
Surgical gown, single-use
Device class
Class I
Regulation number
880.6265
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical gown, single-use

Similar devices

Other devices filed under FDA product code FME (Gown, Examination).

Other devices from Hygitech

See all devices from Hygitech →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)