Skip to content

Aloetouch Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural Colour

by WRP Asia Pacific Sdn. Bhd.

510(k) K040503

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040503 Date16 Mar 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0162-2018 FDA Class II initiated 23 Oct 2017

    Possible open seal on top portion of the package. Could cause breach of sterility.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KGO
Device Class
Class I
Regulation
21 CFR Part 878.4460
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from WRP Asia Pacific Sdn. Bhd.

See all devices from WRP Asia Pacific Sdn. Bhd. →