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SEJONG Surgical Gown Soft GSGW971

by Sejong Healthcare Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08809518442430 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SEJONG Surgical Gown Soft
Generic Name
Surgical gown, single-use
Model / Reference
GSGW971
Primary DI / UDI-DI
08809518442430
510(k) Number
FDA Product Code
FYA
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K220435)

Other devices from Sejong Healthcare Co., Ltd.

Properties

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

Other properties (8)

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