Reference Source

INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD · 89-08 · HONG KONG SAR

For INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD, import alert is 89-08; country is HONG KONG SAR; 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 OMAR Powder-Free Nitrile Examination Gloves White | OMAR Powder-Free Nitrile Examination Gloves White; product code is 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - IG Rubber examination gloves, powder-free; date published is 02/27/2024; address is Suite 1606,16th Floor,The Gateway , Harbour City, HONG KONG SAR, verified against its source on 2026-09-30.

Firm
INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD 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
HONG KONG SAR verified
Address
Suite 1606,16th Floor,The Gateway , Harbour City, HONG KONG SAR verified
Date published
02/27/2024 verified
Product code
80 L - - ZA Glove, Patient Examination, Poly | 80 O - - IG Rubber examination gloves, powder-free each item verified
Product
OMAR Powder-Free Nitrile Examination Gloves White | OMAR Powder-Free Nitrile Examination Gloves White 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

INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD Date Published : 02/27/2024 Suite 1606,16th Floor,The Gateway , Harbour City, HONG KONG SAR

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

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: 02/27/2024 Desc: OMAR Powder-Free Nitrile Examination Gloves White 80 O - - IG Rubber examination gloves, powder-free Date Published: 02/27/2024 Desc: OMAR Powder-Free Nitrile Examination Gloves White

— all from 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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