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Critical Cover 615

by Alphaprotech, Inc.

Critical Cover 615 is a Class II device made by Alphaprotech, Inc., cleared under FDA 510(k) K890128 on 14 Feb 1989 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 10817583020052), 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

510(k) K890128

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10817583020052 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK890128 Date14 Feb 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K890128 decided 14 Feb 1989 Active
  • FDA GUDID UDI-DI 10817583020052 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K890128
  2. Listed FDA GUDID 10817583020052

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Critical Cover
Generic name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Ref / Catalog
615
Primary DI / UDI-DI
10817583020052
510(k) Number
FDA product code
FXX
GMDN term
Surgical/medical face mask, non-antimicrobial, single-use
Device class
Class II
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, non-antimicrobial, single-use

Cleared under the same submission (K890128)

and 8 more cleared under K890128

Similar devices

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

Other devices from Alphaprotech, Inc.

See all devices from Alphaprotech, Inc. →

Properties

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