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791965XL

by Impact Products, LLC

791965XL is a Class I device made by Impact Products, LLC, cleared under FDA 510(k) K982872 on 15 Oct 1998 and listed in FDA GUDID since 25 Jun 2020 (UDI-DI B340791965XL1), 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 ongoing

1 closed

Documents

510(k) K982872

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 NumberB340791965XL1 UDI-DI Date25 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982872 Date15 Oct 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982872 decided 15 Oct 1998 Active
  • FDA GUDID UDI-DI B340791965XL1 listed 25 Jun 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0909-06 FDA Unclassified (pre-2012) initiated 10 Apr 2006 on shared 510(k) K982872

    FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K982872
  2. Recall initiated FDA recalls Z-0909-06
  3. Listed FDA GUDID B340791965XL1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Vinyl examination/treatment glove, non-powdered
Model / Ref / Catalog
791965XL, 791965
Primary DI / UDI-DI
B340791965XL1
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 (K982872)

and 4 more cleared under K982872

Similar devices in this category

Other devices filed under Vinyl examination/treatment glove, non-powdered.

Other devices from Impact Products, LLC

See all devices from Impact Products, LLC →

Properties

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