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Criterion 5703115

by Henry Schein, Inc.

Criterion 5703115 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K133070 on 22 Jun 2015 and listed in FDA GUDID since 26 Jun 2023 (UDI-DI 10304040165253), 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) K133070

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 Number10304040165253 UDI-DI Date26 Jun 2023ListedStatusListed 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 10304040165253 listed 26 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133070
  2. Listed FDA GUDID 10304040165253

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Criterion
Generic name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Ref / Catalog
5703115
Primary DI / UDI-DI
10304040165253
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 (K133070)

and 8 more cleared under K133070

Similar devices

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

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)