Skip to content

JR.MEDIK Latex Surgeon’s Gloves Powder Free

by JR Engineering & Medical Technologies (M) Sdn Bhd

510(k) K192328

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK192328 Date10 Mar 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
FDA applicant
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Device Class
Class I
Regulation
21 CFR Part 878.4460
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from JR Engineering & Medical Technologies (M) Sdn Bhd

See all devices from JR Engineering & Medical Technologies (M) Sdn Bhd →