Skip to content

ProGear FM86010

by Prestige Ameritech

ProGear FM86010 is a Class II device made by Prestige Ameritech, listed in FDA GUDID since 17 Sep 2019 (UDI-DI 00852212003498), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852212003498 UDI-DI Date17 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ProGear
Generic name
Surgical/medical face mask, single-use
Model / reference
FM86010
Primary DI / UDI-DI
00852212003498
FDA product code
FXX
GMDN term
Surgical/medical face mask, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, single-use

Similar devices

Other devices filed under FDA product code FXX (Mask, Surgical).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)