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Plasdent Fluid Proof Earloop Mask MK1

by Plasdent Corp. 6 variants

Plasdent Fluid Proof Earloop Mask MK1 (MK1-2) is a Class II device made by Plasdent Corp., cleared under FDA 510(k) K133070 on 22 Jun 2015 and listed in FDA GUDID since 21 Sep 2018 (UDI-DI D832MK12), active as of 22 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 22 Oct 2026

Documents

510(k) K133070

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD832MK12 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133070 Date22 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133070 decided 22 Jun 2015 Active
  • FDA GUDID UDI-DI D832MK12 listed 21 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133070
  2. Listed FDA GUDID D832MK12

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plasdent Fluid Proof Earloop Mask
Generic name
Surgical/medical respirator, antimicrobial
Model / Ref / Catalog
MK1, MK1-2
Primary DI / UDI-DI
D832MK12
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical respirator, antimicrobial
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical respirator, antimicrobial

Cleared under the same submission (K133070)

and 8 more cleared under K133070

Similar devices

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

Other devices from Plasdent Corp.

See all devices from Plasdent Corp. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)