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Customed 712057693047

by Customed, Inc.

Customed 712057693047 (9003047) is a Class I device made by Customed, Inc., cleared under FDA 510(k) K010198 on 23 Feb 2001 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890030477), active as of 23 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 23 Oct 2026

Documents

510(k) K010198

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM20890030477 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010198 Date23 Feb 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010198 decided 23 Feb 2001 Active
  • FDA GUDID UDI-DI M20890030477 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010198
  2. Listed FDA GUDID M20890030477

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Customed
Generic name
Hevea-latex surgical glove, powdered
Model / Ref / Catalog
712057693047, 9003047
Primary DI / UDI-DI
M20890030477
510(k) Number
FDA product code
KGO
GMDN term
Hevea-latex surgical glove, powdered
Device class
Class I
Regulation number
878.4460
GUDID distribution status
In Commercial Distribution
Size
Circumference — 6.0 Inch

Related devices

Category: Hevea-latex surgical glove, powdered

Cleared under the same submission (K010198)

and 1 more cleared under K010198

Similar devices

Other devices filed under FDA product code KGO (Surgeon'S Gloves).

Other devices from Customed, Inc.

See all devices from Customed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)