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Chemotherapy Gloves

by 3A Glove Sdn. Bhd. Malaysia 510(k)

510(k) K230847 Product code LZA

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230847 Date29 Sep 2023ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LZA
Device Class
Class I
Regulation
21 CFR Part 880.6250
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from 3A Glove Sdn. Bhd.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K230847 24 fields · synced 22 Oct 2026