GMP Medicare Sdn Bhd(F25) · 89-08 · MALAYSIA
For GMP Medicare Sdn Bhd(F25), 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 CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange; product code is 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 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 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 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 08/23/2022; address is Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor MALAYSIA, verified against its source on 2026-09-30.
- Firm
- GMP Medicare Sdn Bhd(F25) 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/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor MALAYSIA verified
- Date published
- 08/23/2022 verified
- Product code
- 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 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 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs | 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
- CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | SKINTX Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | GMP Medicare Ultrasoft UL Nitrile Examination Powder-Free Gloves Orange each item verified
What the source says
GMP Medicare Sdn Bhd(F25) Date Published : 08/23/2022 Lot/PT 64593, Jalan Dahlia/KU8 , Kawasan Perindustrian Meru Timur , Klang, Selangor 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 - - YY Glove, Patient Examination, Latex Date Published: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 80 L - - YY Glove, Patient Examination, Latex Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 80 L - - YY Glove, Patient Examination, Latex Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 80 L - - ZA Glove, Patient Examination, Poly Date Published: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 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 - - ZA Glove, Patient Examination, Poly Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 80 L - - ZA Glove, Patient Examination, Poly Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 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: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 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 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 08/23/2022 Desc: SKINTX Nitrile Examination Powder Free Examination Gloves Black 80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Date Published: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 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