Medicom AssureTouch 9985-SP6

by AMD Medicom Inc

Medicom AssureTouch 9985-SP6 is a Class I device made by AMD Medicom Inc, cleared under FDA 510(k) K171873 on 15 Nov 2017 and listed in FDA GUDID since 23 Aug 2022 (UDI-DI 20686864059503), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number20686864059503 UDI-DI	Date23 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171873	Date15 Nov 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 20686864059503
FDA 510(k) database 510(k) number K171873

Across registries

2 registries list this device

FDA 510(k) K171873 decided 15 Nov 2017 Active
FDA GUDID UDI-DI 20686864059503 listed 23 Aug 2022 Listed

Timeline

2 dated events

15 Nov 2017 Cleared FDA 510(k) K171873
23 Aug 2022 Listed FDA GUDID 20686864059503

Coverage

1 jurisdiction

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Withdrawn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-SP6

Primary DI / UDI-DI: 20686864059503
510(k) Number: K171873
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

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, all answered No)