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ZD Isolation Gown-CP ZDB120002A

by Xuchang Zhengde Environstar Medical Products Co., Ltd.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06971004782886 UDI-DI Date17 Apr 2020ListedStatusListed 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  • Withdrawn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
ZD Isolation Gown-CP
Generic Name
Isolation gown, single-use
Model / Reference
ZDB120002A
Primary DI / UDI-DI
06971004782886
FDA Product Code
OEA
GMDN Term
Isolation gown, single-use
Device Class
Class I
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isolation gown, single-use

Other devices from Xuchang Zhengde Environstar Medical Products Co., Ltd.

See all devices from Xuchang Zhengde Environstar Medical Products Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No