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PlastCare PG-MBK1

by Proguard Health Inc.

PlastCare PG-MBK1 is a Class II device made by Proguard Health Inc., cleared under FDA 510(k) K023755 on 10 Jun 2003 and listed in FDA GUDID since 2 Jul 2021 (UDI-DI D066PGMBK11), 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) K023755

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 NumberD066PGMBK11 UDI-DI Date2 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023755 Date10 Jun 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023755 decided 10 Jun 2003 Active
  • FDA GUDID UDI-DI D066PGMBK11 listed 2 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023755
  2. Listed FDA GUDID D066PGMBK11

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PlastCare
Generic name
Surgical/medical respirator, non-antimicrobial, single-use
Model / Ref / Catalog
PG-MBK1
Description
Ear-Loop Mask Black (Level 1)
Primary DI / UDI-DI
D066PGMBK11
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical respirator, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Surgical/medical respirator, non-antimicrobial, single-use

Cleared under the same submission (K023755)

and 2 more cleared under K023755

Similar devices

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

Other devices from Proguard Health Inc.

See all devices from Proguard Health Inc. →

Properties

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