# GMP MEDICARE SDN BHD · 89-08 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Lot 2431 Mukin Port Dickson Sendayan , Jalan Siliau , Siliau, Negeri Sembilan MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 09/21/2026 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in its own passage below)_
- **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 _(verified: each item appears in its own passage below)_

## 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

## Where each value comes from

This source states these in separate places, so each value is shown with the passage that states it.

### Product code

> 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:

### 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:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-30. Review by: 2026-11-29.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).