Reference Source

GMP Medicare Sdn Bhd(F25) · 89-08 · MALAYSIA

For GMP Medicare Sdn Bhd(F25) · 89-08 · MALAYSIA, import alert is 89-08; 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)"; country is MALAYSIA; product is Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | 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; 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 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; 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 2026-09-16.

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 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 each item verified
Product
Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | CAREBK9 Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | SKINTX Nitrile Examination Powder Free Examination Gloves Black | Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves | 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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 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: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black 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: SKINTX Nitrile Examination Powder Free Examination Gloves Black 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: 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: 10/17/2025 Desc: Tronex 9128 Series New Age Powder Free Nitrile Examination Gloves 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: 08/23/2022 Desc: CAREBK9 Nitrile Examination Powder Free Examination Gloves Black

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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