GMP MEDICARE SDN BHD · 89-08 · MALAYSIA
For GMP MEDICARE SDN BHD, import alert is 89-08; country is MALAYSIA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange; product code is 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 Q - - DO Fentanyl and other opioid protection glove; date published is 09/21/2026; address is Lot 2431 Mukin Port Dickson Sendayan , Jalan Siliau , Siliau, Negeri Sembilan MALAYSIA, verified against its source on 2026-09-30.
- Firm
- GMP MEDICARE SDN BHD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- MALAYSIA verified
- Address
- Lot 2431 Mukin Port Dickson Sendayan , Jalan Siliau , Siliau, Negeri Sembilan MALAYSIA verified
- Date published
- 09/21/2026 verified
- Product code
- 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 Q - - DO Fentanyl and other opioid protection glove each item verified
- Product
- GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange each item verified
What the source says
GMP MEDICARE SDN BHD Date Published : 09/21/2026 Lot 2431 Mukin Port Dickson Sendayan , Jalan Siliau , Siliau, Negeri Sembilan MALAYSIA
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
80 L - - ZA Glove, Patient Examination, Poly Date Published: 09/21/2026 Desc: GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange Notes: 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 09/21/2026 Desc: GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange Notes: 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 09/21/2026 Desc: GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange Notes: 80 Q - - DO Fentanyl and other opioid protection glove Date Published: 09/21/2026 Desc: GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange Notes:
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html