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Hygitech Hy-07011

by Hygitech

Hygitech Hy-07011 is a Class II device made by Hygitech, cleared under FDA 510(k) K173062 on 25 Jan 2018 and listed in FDA GUDID since 15 Dec 2020 (UDI-DI 03615140000406), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K173062

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03615140000406 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173062 Date25 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173062 decided 25 Jan 2018 Active
  • FDA GUDID UDI-DI 03615140000406 listed 15 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173062
  2. Listed FDA GUDID 03615140000406

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hygitech
Generic name
Face splash shield, single-use
Model / Ref / Catalog
HY-07011
Primary DI / UDI-DI
03615140000406
510(k) Number
FDA product code
FXX
GMDN term
Face splash shield, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Face splash shield, single-use

Cleared under the same submission (K173062)

and 5 more cleared under K173062

Similar devices

Other devices filed under FDA product code FXX (Mask, Surgical).

Other devices from Hygitech

See all devices from Hygitech →

Properties

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