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Medicom AssureTouch 9985-C

by AMD Medicom Inc 2 variants

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 2 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240629 Date28 May 2024DecidedStatusActive
United StatesGUDID listing Number10686864060137 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medicom AssureTouch
Generic name
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Ref / Catalog
9985-C
Primary DI / UDI-DI
10686864060137
510(k) Number
FDA product code
LZC, LZA
GMDN term
Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Device class
Class I
Regulation number
880.6250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Cleared under the same submission (K171873)

Show all (12)

Cleared under the same submission (K240629)

Other devices from AMD Medicom Inc

See all devices from AMD Medicom Inc →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No