DeviceSignal · 510(k) cleared
Gmp Medicare Sdn. Bhd.
FDA 510(k) decision recorded 2026-09-08 · K260312 · Special 510(k)
Event510(k) cleared
Effective2026-09-08
DecisionSESE
On 2026-09-08 the FDA recorded a 510(k) clearance decision for Gmp Medicare Sdn. Bhd., for Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and…. Clearance K260312. Product code LZA. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K260312
- Applicant
- Gmp Medicare Sdn. Bhd.
- Device
- Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
- Decided on
- 2026-09-08
- Received on
- 2026-01-30
- Decision
- SESE
- Clearance type
- Special
- Product code
- LZA
- Review days
- 221
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K260312- Snapshot hash
a3a25028eeae44912b95531a87efac5a606d6a01c346404e56e7ec7fd97b2d35- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
4174bc8971a1035645e0591ccc8af1fc543a838547c2a48da4561fc520a23570- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)