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PremierPro 4035

by Prestige Ameritech

PremierPro 4035 is a Class I device made by Prestige Ameritech, cleared under FDA 510(k) K100326 on 24 Mar 2010 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00818566012661), 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) K100326

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 Number00818566012661 UDI-DI Date24 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100326 Date24 Mar 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100326 decided 24 Mar 2010 Active
  • FDA GUDID UDI-DI 00818566012661 listed 24 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100326
  2. Listed FDA GUDID 00818566012661

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PremierPro
Generic name
Vinyl examination/treatment glove, non-powdered
Model / Ref / Catalog
4035
Primary DI / UDI-DI
00818566012661
510(k) Number
FDA product code
LYZ
GMDN term
Vinyl examination/treatment glove, non-powdered
Device class
Class I
Regulation number
880.6250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vinyl examination/treatment glove, non-powdered

Cleared under the same submission (K100326)

and 4 more cleared under K100326

Similar devices

Other devices filed under FDA product code LYZ (Vinyl Patient Examination Glove).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)